Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000923561
Ethics application status
Approved
Date submitted
12/09/2023
Date registered
31/07/2024
Date last updated
31/07/2024
Date data sharing statement initially provided
31/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the effect of the soft robotic assisted hand training on upper limb function, lung function and quality of life in stroke survivors undergoing rehabilitation
Scientific title
A randomised controlled trial investigating the effect of the soft robotic assisted hand training on upper limb function, lung function and quality of life in stroke survivors undergoing rehabilitation
Secondary ID [1] 310585 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 331444 0
Ischemic Stroke 332495 0
Thrombotic Stroke 332496 0
Embolic Stroke 332497 0
Hemorrhagic Stroke 332498 0
Intracerebral Hemorrhage 332499 0
Subarachnoid Hemorrhage 332500 0
Upper limb weakness 332501 0
Impaired lung function 332502 0
Loss of Fine Motor Skills upper limb 332503 0
Spasticity 332504 0
Impaired Coordination of upper limb 332505 0
Upper limb contractures 332506 0
Upper limb pain 332507 0
Shoulder Subluxation 332508 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328183 328183 0 0
Physiotherapy
Stroke 328184 328184 0 0
Haemorrhagic
Stroke 329188 329188 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study utilized the Soft Robotic Glove from Maitland, China, to address symptoms in stroke patients, including spasms, hand weakness, and paralysis. The glove is designed for rehabilitation and enhances various hand functions while stimulating brain nerves for improved functionality. Pinch training involves opposing each finger individually, while mirror training uses the healthy hand to lead the affected side fingers in synchronized actions. Fine motor training utilizes a power glove to drive each affected finger to perform extension and flexion exercises, while functional training simulates daily activities that require hand grip, such as gripping a water bottle.

Enhanced Soft Robotic Assisted Hand Training Protocol
A Pilot Randomized Controlled Trial (RCT) will be conducted to evaluate the feasibility of Soft Robotic-Assisted Hand Training with Standard Therapy (SRAHT-ST) on the upper limb function, lung function, and quality of life of stroke survivors, as compared to Standard Therapy alone (ST).

Recruitment will be from the Petaling Jaya community, with assessments and treatments at Dewan Community Desa Mentari, Petaling Jaya. Two experienced physiotherapists (researchers and research assistants) with more than five years of experience and degree holders will conduct the study. The researcher will conduct the assessments such as screening, baseline assessments, implementing interventions, and evaluating study outcomes. The duration is one-hour treatment sessions, three times per week for eight weeks (24 sessions), under the supervision of physiotherapists. The program will also incorporate the Graded Repetitive Arm Supplementary Program (GRASP). This study program focuses on graded and repetitive exercises to enhance neuroplasticity and motor skills in the affected arm, including reaching, grasping, and object manipulation. The program comprises five sections: Stretching, Arm Strengthening, Hand Strengthening, Coordination, and Hand Skills. These sections include six key exercise components: Range of motion, Strengthening, Repetitions of the stroke-affected arm and hand, Weight-bearing, Trunk control, and Repetitions using both arms. Participants will be given logbooks and GRASP guidelines as a home exercise program (Katy, 2023). The assessments will be measured at baseline, 4-week, and 8-week follow-ups.



1. Experimental Group: SRAHT Combined Standard therapy ( ST )
The experimental group will perform task-specific training using a soft robotic glove with GRASP. In 60-minute sessions, participants will perform 20 minutes of hand-functional tasks using a soft robotic glove, and 40 minutes of GRASP exercises. A researcher will monitor sessions for proper execution and intensity. Participants will engage in home exercise programs (HEP) aligned with GRASP guidelines.


Task performing with Soft Robotic Glove (SRAHT )
1. The Box and Block Test (BBT):
Participants will grasp 2.5 cm x 2.5 cm wooden blocks from a box of 150 within 1 minute, lifting and crossing the 15.2 cm barrier at their midline and releasing the box using a soft robotic glove (mirror mode). Participants will be given 5 minutes to practice the task before being evaluated.
2. Water bottle task:
Participants will hold an empty plastic water bottle (diameter: 76mm) using a soft robotic glove (mirror mode) for 5-10 minutes. A 5-minute practice precedes the water bottle task.
3. Fork grasping tasks:
Participants will lift and manipulate a fork using a soft robotic glove with mirror mode for 5-10 minutes. A 5-minute practice precedes the fork-grasping tasks.
4. Pen grasping tasks:
Participants will lift and manipulate a pen using a soft robotic glove with mirror mode for 5-10 minutes. A 5-minute practice precedes the pen-grasping tasks.

The Graded Repetitive Arm Supplementary Programme (GRASP)- Standard therapy

SECTION 1: STRETCHING
The first section of exercises is to help warm up your upper extremities.
1. Total arm stretch
10 counts
2 repetition

2. Shoulder shrug
3 counts
10 repetitions

3. The twist right and left
three counts
five repetitions

4. Hand and wrist stretch
3 counts
5 repetitions


SECTION 2: INCREASING ARM STRENGTH
The exercises are focused on increasing arm strength

1. Push up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

2. One arm push-up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

3. Chairs up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

4. Shoulder exercise: arm to the front (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

5. Shoulder exercise: arm to side (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

6. Elbow exercise (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

7. Wrist Exercise Part 1 (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

8. Wrist exercise part 2 (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

SECTION 3: HAND STRENGTHENING
The exercise focuses on increasing the strength of the hand.

13. Grip power (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

14. Finger power
1. Place the putty on the table and roll it into a thick rope. Take each finger of your weaker hand, starting with your thumb, and push into the putty.
2. After you finish all five fingers, re-roll the putty with your weaker hand.
3. Do this whole sequence five times.

15. Finger twist
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

16. Finger strength
1. Roll the putty into a ball with a weaker hand.
2. Hold the putty ball in your stronger hand.
3. Take one finger at a time of your weaker hand, start with your thumb, and push it into the putty ball.
4. Do not hyperextend the finger – don’t bend the finger backwards.
5. Repeat the sequence ten times.

17. Cutting

Repeat 5 times
Repeat 10 times

SECTION 4: COORDINATION
The exercises will focus on increasing coordination and the ability to do your day-to-day activities.

18. Waiter-cup (20 times)
Repeat 3 times
Repeat 2 times (as fast as you can)

19. Advanced waiter (20 times)
Repeat the whole sequence 3 times.

20. Pouring
Pour back and forth 20 times

21. Rolling ball with a partner
Catches the ball 20 times.

22. Rolling ball with no partner
Catches the ball 20 times.

23. Drop and catch the ball
Repeat 20 times.
Switch and drop the ball with the weaker hand 20 times.

24. Total arms stretch

SECTION 5: HAND SKILLS (The exercise is to help improve hand skills).
25. Laundry
Repeat 5 times.

26. Button T-shirt
1. Take a shirt with buttons out of your closet.
2. Put it on and push up all the buttons.
3. Now undo the buttons. Repeat 5 times.

27. Hang up the cloth
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

28. Lego
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

29. Picks up sticks
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

30. Paper clip chain
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

31. Poker Chips
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

32. Open the jar
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

33. Drying off
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

Group Size
1 hour session for face-to-face group training will be divided into 2 groups: The experiment is 5 participants, and the control group is 5 participants.
• Experimental Treatment Group: 5 participants for the first hour.
• Control Treatment Group: 5 participants for the second hour.

Strategies for assessing and monitoring adherence to the intervention include:
1. Attendance Tracking:
Utilize checklists to track client attendance at each session. Conduct follow-ups after sessions to identify and address any challenges hindering adherence.

2. Appointment Reminders:
Send reminders one day before sessions.

3. Preparation and Punctuality:
Encourage participants to arrive 15 minutes early to prepare mentally and physically.
Call participants running late by more than 15 minutes to avoid disruptions.

4. Cancellation Management:
Promptly reschedule canceled sessions to prevent treatment gaps.

5. Supervised Intervention:
A researcher supervises the intervention to ensure correct execution and required intensity.

6. Home Exercise Programs (HEP):
Implement HEP aligned with GRASP guidelines for both groups to encourage adherence outside supervised sessions.

7. Performance Evaluation:
Evaluate adherence to intervention guidelines using performance assessment methods at 0, four weeks, and eight weeks.

8. Feedback and Monitoring:
Regular communication channels with participants for feedback and progress monitoring. Address challenges promptly to maintain overall adherence to program requirements and goals.
-Ask the participant and family if there are any issues with the exercises (query if too easy, too hard, query pain)
-Check to see if the log sheets are done. Discuss barriers and potential solutions if exercise compliance is low (< 45 min daily).

Level of Intensity and Assessment:
The duration of one training session is 60 minutes with low intensity to ensure safety and proper exercise technique. Borg RPE is used to assess participants' perceived exertion.
Intervention code [1] 326989 0
Treatment: Other
Intervention code [2] 327818 0
Treatment: Devices
Intervention code [3] 327819 0
Rehabilitation
Comparator / control treatment
Control group: Standard therapy (ST)
The control group will perform task-specific training GRASP for 60-minute sessions. A researcher will monitor sessions for proper execution and intensity. Participants will engage in home exercise programs (HEP) aligned with GRASP guidelines.

The Graded Repetitive Arm Supplementary Programme (GRASP)- Standard therapy

The Graded Repetitive Arm Supplementary Programme (GRASP)- Standard therapy

SECTION 1: STRETCHING
The first section of exercises is to help warm up your upper extremities.
1. Total arm stretch
10 counts
2 repetition

2. Shoulder shrug
3 counts
10 repetitions

3. The twist right and left
three counts
five repetitions

4. Hand and wrist stretch
3 counts
5 repetitions


SECTION 2: INCREASING ARM STRENGTH
The exercises are focused on increasing arm strength

1. Push up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

2. One arm push-up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

3. Chairs up (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

4. Shoulder exercise: arm to the front (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

5. Shoulder exercise: arm to side (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

6. Elbow exercise (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

7. Wrist Exercise Part 1 (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

8. Wrist exercise part 2 (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

SECTION 3: HAND STRENGTHENING
The exercise focuses on increasing the strength of the hand.

13. Grip power (Count for 3)
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

14. Finger power
1. Place the putty on the table and roll it into a thick rope. Take each finger of your weaker hand, starting with your thumb, and push into the putty.
2. After you finish all five fingers, re-roll the putty with your weaker hand.
3. Do this whole sequence five times.

15. Finger twist
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

16. Finger strength
1. Roll the putty into a ball with a weaker hand.
2. Hold the putty ball in your stronger hand.
3. Take one finger at a time of your weaker hand, start with your thumb, and push it into the putty ball.
4. Do not hyperextend the finger – don’t bend the finger backwards.
5. Repeat the sequence ten times.

17. Cutting

Repeat 5 times
Repeat 10 times

SECTION 4: COORDINATION
The exercises will focus on increasing coordination and the ability to do your day-to-day activities.

18. Waiter-cup (20 times)
Repeat 3 times
Repeat 2 times (as fast as you can)

19. Advanced waiter (20 times)
Repeat the whole sequence 3 times.

20. Pouring
Pour back and forth 20 times

21. Rolling ball with a partner
Catches the ball 20 times.

22. Rolling ball with no partner
Catches the ball 20 times.

23. Drop and catch the ball
Repeat 20 times.
Switch and drop the ball with the weaker hand 20 times.

24. Total arms stretch

SECTION 5: HAND SKILLS (The exercise is to help improve hand skills).
25. Laundry
Repeat 5 times.

26. Button T-shirt
1. Take a shirt with buttons out of your closet.
2. Put it on and push up all the buttons.
3. Now undo the buttons. Repeat 5 times.

27. Hang up the cloth
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

28. Lego
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

29. Picks up sticks
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

30. Paper clip chain
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

31. Poker Chips
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

32. Open the jar
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions

33. Drying off
2 sets of 8 repetitions
2 sets of 10 repetitions
3 sets of 10 repetitions
Control group
Active

Outcomes
Primary outcome [1] 336053 0
Upper extremity performance (coordination, dexterity, and functioning ) will be assessed using Action Research Arm Test (ARAT).
Timepoint [1] 336053 0
Time one at 0-week ( Baseline )
time two at four weeks ( post-test )
time three at eight weeks ( post-test )
Primary outcome [2] 337170 0
Upper extremity motor functioning, sensation, balance, joint range of motion, and joint pain will be assessed by using the Fugl-Meyer UE Assessment (FMA- UE).
Timepoint [2] 337170 0
Time one at 0-week ( Baseline )
time two at four weeks ( post-test )
time three at eight weeks ( post-test )
Primary outcome [3] 337171 0
Lung function (The Forced Vital Capacity (FVC) and The Forced Expiratory Volume in one second (FEV1)) will be assessed by a spirometry test.
Timepoint [3] 337171 0
Time one at 0-week ( Baseline)
time two at four weeks ( post-test )
time three at eight weeks ( post-test )
Secondary outcome [1] 426693 0
Lung function (The Forced Vital Capacity (FVC) and The Forced Expiratory Volume in one second (FEV1)) will be assessed by a spirometry test.
Timepoint [1] 426693 0
time one at 0-week ( Baseline )
time two at four weeks ( post-test )
time three at eight weeks ( post-test )

Eligibility
Key inclusion criteria
1. Participants must have received a clinical diagnosis of stroke.
2. The ages of 18 and 80 years.
3. Participants minimum Barthel Index (BI) score of 30.
4. Participants must presently have upper extremity (UE) hemiplegia with Brunnstrom Recovery Stages III or IV, signifying a specific level of motor recovery.
5. Participants should be able to understand verbal instructions in either Malay or English
6. Participants must be able to express thoughts effectively and provide opinions adequately, without displaying signs of facial palsy.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe aphasia
• Neuromuscular disorders such as Parkinson's, Dementia, Alzheimer's,
• Cardiac or pulmonary disorders that could affect rehabilitation
• upper extremities fracture , upper extremities arthritis , upper extremities osteoporosis
• Inability to sit upright with support for 40 minutes due to postural hypotension or pressure intolerance
• Severe sensory and visual impairments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of the experiments is assigned by stratified random.
For the Pilot Randomized control trial, 10 participants will be recruited. Participants’ allocation will be randomly assigned in a 1:1 ratio to either five participants in the experimental group or 5 participants in the control group based on permuted block sequences that are stratified according to demographic, age, gender, and baseline ARAT and BBT scores.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE
The study's sample size was determined using G-Power software version 3.1.9.7. The sample size was calculated based on the F test of ANOVA repeated measures within factors, with a significance level of 0.05 and a power of 0.90. The effect size, indicated by Cohen's f, was computed to be 0.23 (Calabro et al. 2021). For the pilot RCT study, we calculated that 23% will be 10 participants. Therefore, the experimental and control groups will have 5 participants each.

DATA ANALYSIS
The data collected for this study will be analyzed using Statistical Products and Service Solution (SPSS) version 26.0. The significance level for the study is set at 5%. We will conduct a normality test, specifically the Shapiro-Wilk test (Shapiro & Wilk, 1965), to examine the distribution of baseline data. This test is essential to ensure that the assumptions of parametric tests are met. Calculate descriptive statistics for all assessment scores, such as median, mean, interquartile range, and standard deviation (Field, 2013).
A two-way repeated measures ANOVA within-subject will be applied to compare the effect of a combination of SRAHT-ST or ST alone on upper limb function, lung functions, and quality of life among stroke survivors at three-time points (baseline, four weeks, and eight weeks) to detecting changes over time (Girden, 1992). If the data do not meet the assumptions of normality, indicating non-normally distributed data, the Freedman Test will be applied as a nonparametric alternative (Freedman, 1981) to ensure robust analysis even with non-normally distributed data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25767 0
Malaysia
State/province [1] 25767 0
Petaling Jaya , SELANGOR

Funding & Sponsors
Funding source category [1] 314794 0
Self funded/Unfunded
Name [1] 314794 0
Nik Intan Shakina binti Ramli
Country [1] 314794 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Kampus Kuala Lumpur, Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 317734 0
None
Name [1] 317734 0
Address [1] 317734 0
Country [1] 317734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313807 0
IRB/IEC Research Ethics Committee UKM (RECUKM)
Ethics committee address [1] 313807 0
Ethics committee country [1] 313807 0
Malaysia
Date submitted for ethics approval [1] 313807 0
28/06/2024
Approval date [1] 313807 0
09/07/2024
Ethics approval number [1] 313807 0
JEP 2024-261

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129406 0
Dr Nor Azura binti Azmi
Address 129406 0
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 129406 0
Malaysia
Phone 129406 0
+60176172700
Fax 129406 0
Email 129406 0
[email protected]
Contact person for public queries
Name 129407 0
NIK INTAN SHAKINA RAMLI
Address 129407 0
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur, Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 129407 0
Malaysia
Phone 129407 0
+60176172700
Fax 129407 0
Email 129407 0
[email protected]
Contact person for scientific queries
Name 129408 0
Nor Azura binti Azmi
Address 129408 0
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur, Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 129408 0
Malaysia
Phone 129408 0
+60176172700
Fax 129408 0
Email 129408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In this study, the following data will be shared:

1. **Participant Demographics**: Age, gender, and duration of stroke for each participant.
2. **Baseline Assessments**: Scores from the Action Research Arm Test (ARAT), Fugl-Meyer Upper Extremity Assessment, spirometry test results, and EQ-5D-5L questionnaire.
3. **Feasibility Metrics**: Recruitment, retention, and adherence rates of participants in both the experimental and control groups.
4. **Intervention Details**: Description of the Soft Robotic-Assisted Hand Training with Standard Therapy (SRAHT-ST) and Standard Therapy (ST) protocols, including session frequency, duration, and types of exercises.
5. **Outcome Measures**: Changes in upper limb function, lung function, and quality of life from baseline to 4-week and 8-week follow-ups for both groups.
6. **Statistical Analyses**: Descriptive and inferential statistics, including results of ANOVA, comparing the outcomes between the SRAHT-ST and ST groups.

These data will help in evaluating the effectiveness and feasibility of the SRAHT-ST intervention compared to standard therapy alone.
When will data be available (start and end dates)?
Data Availability:
• Beginning Date: [15 November 2024]
• End Date: [15 December 2024]
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
NAME:NOR AZURA BINTI AZMI
ID NO: K016572
FACULTY SAINS KESIHATAN, PUSAT KAJIAN KEPERLUAN KHAS DAN REHABILITASI (IcaRehab)
DEPARTMENT/UNIT: Physiotherapy
EMAIL: [email protected]
MOBILE NUMBER: 011-20971716


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24010Ethical approval    386587-(Uploaded-21-07-2024-16-43-54)-JEP-2024-261.pdf



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