Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000695808
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
29/06/2012
Date last updated
1/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to evaluate an intensive upper limb rehabilitation program after stroke
Scientific title
A pilot study investigating whether adults with stroke experience greater dexterity after using a Saebo splint in addition to their usual rehabilitation program compared to usual rehabilitation program alone.
Secondary ID [1] 279754 0
Nil.
Universal Trial Number (UTN)
Nil.
Trial acronym
Nil.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb hemiplegia 285621 0
Stroke 286790 0
Condition category
Condition code
Stroke 285811 285811 0 0
Ischaemic
Stroke 285812 285812 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 287102 287102 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a specific mechanical dynamic orthosis plus Occupational Therapy training (intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task­-specific home exercise program using the mechanical dynamic orthosis).
The mechanical dynamic orthosis (Saebo splint) is worn on the hemiplegic arm only, and may be used up to twice daily (5 x per week) for a maximum session length of 60 minutes for 8 weeks. All sessions are administered by an occupational therapist within the hospital clinic environment.
Intervention code [1] 284202 0
Rehabilitation
Comparator / control treatment
Usual Occupational Therapy rehabilitation program: at the participating hospitals this will include a minimum of 1 x session per day with an occupational therapist focused on improving range of movement, active grasp and release, and reach. Treatment sessions are based on task-specific motor training, and will be approximately 45 minute session length. The program duration is 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 286451 0
Range of movement measured using a goniometer: Trapezius (shoulder elevators)
Deltoid middle (shoulder abductors)
Pectoralis major (shoulder adductors)
Deltoid anterior (shoulder flexors)
Deltoid posterior (shoulder extensors)
Subscapularis
(shoulder internal rotators)
Infraspinatus (shoulder external rotators)
Biceps brachii (elbow flexors)
Triceps (elbow extensors)
Wrist extensors (extensor carpi ulnaris/radialis)
Wrist flexors (flexor carpi radialis/ulnaris)
Timepoint [1] 286451 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Primary outcome [2] 287421 0
Grip Strength measured with Dynamometry
Timepoint [2] 287421 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Secondary outcome [1] 295914 0
Dexterity as measured using the Box and Block test of dexterity.
Timepoint [1] 295914 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Secondary outcome [2] 295915 0
Functional task performance as measured using the Motor Assessment Scale for Stroke.
Timepoint [2] 295915 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Secondary outcome [3] 295916 0
Pain, as measured using the Stroke Impact Scale.
Timepoint [3] 295916 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Secondary outcome [4] 295917 0
Caregiver assistance required as measured using the Stroke impact Scale.
Timepoint [4] 295917 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).
Secondary outcome [5] 295918 0
Spasticity as measured using the Tardieu Scale for Stroke
Timepoint [5] 295918 0
Baseline (prior to intervention) and post-intervention (after 8-weeks of intervention).

Eligibility
Key inclusion criteria
1. 18 years of age or older (adult),
2. diagnosis of stroke ,
3. Upper limb hemiplegia (score of < 6 on 6 items 6 and/or 7 of the motor Assessment scale [16NL]Alert and oriented to person and place with the ability to complete at a minimum a one step verbal command,
4. Score of 21 or greater on the Mini­ mental State Examination.
5. Adequate English to communicate with the therapist/participate in a rehabilitation program.
6. Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension.
7. Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Medically unsuitable for rehabilitation intervention, for example, inpatients who have been diagnosed as palliative.
2. Using the affected hand and arm, able to volitionally grasp and release a tennis ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
3. Complete flaccidity in the affected upper limb and hand
4. Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
5. History of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy.
6. Moderate to severe oedema

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)
As eligible patients are identified and agree to participate, the on­site investigator will contact a person off­ site who will have 10 sealed condition envelopes. The allocation to the control or treatment group will be advised by phone when the person opens the allocation envelope and this will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer-generated number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
29/09/2011
Date of last participant enrolment
Anticipated
Actual
9/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284651 0
Charities/Societies/Foundations
Name [1] 284651 0
National Stroke Foundation
Country [1] 284651 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Natasha Lannin
Address
Alfred Hospital
Occupational Therapy Department
55 Commercial Road, Prahran VIC 3004
Country
Australia
Secondary sponsor category [1] 283559 0
University
Name [1] 283559 0
Rehabilitation Studies Unit, Sydney Medical School, The University of Sydney
Address [1] 283559 0
PO Box 6, Ryde NSW, 1680
Country [1] 283559 0
Australia
Other collaborator category [1] 276883 0
University
Name [1] 276883 0
University of Newcastle
Address [1] 276883 0
University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308
Country [1] 276883 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286646 0
Sydney South Eastern Health Human Research Ethics Committee - Northern Sector
Ethics committee address [1] 286646 0
Room G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Avoca Street
Randwick NSW 2031
Ethics committee country [1] 286646 0
Australia
Date submitted for ethics approval [1] 286646 0
27/04/2011
Approval date [1] 286646 0
01/07/2011
Ethics approval number [1] 286646 0
1/11/0050
Ethics committee name [2] 287542 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 287542 0
University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308
Ethics committee country [2] 287542 0
Australia
Date submitted for ethics approval [2] 287542 0
Approval date [2] 287542 0
28/10/2011
Ethics approval number [2] 287542 0
H-2011-0263

Summary
Brief summary
This project aims to develop and test the feasibility of a client­centred intervention for improving dexterity for people with stroke. Upper limb hemiplegia is common after stroke, and such people typically achieve lower levels of functional recovery. Many individuals suffering from hemiplegia after stroke exhibit some shoulder and elbow movement but little or no hand function, preventing them from participating in Constraint­ Induced Movement Therapy (CIMT). Using newer technologies such as a mechanical orthoses offers promise for stroke survivors with hemiplegia. However, no direct evidence exists for optimum wearing regimes, training protocols and timing of therapy.

This study will therefore make a significant contribution to healthcare decision making. Participants in the 'treatment' group will be recruited from the Prince of wales in­patient hospital service and will receive an 8­-week intervention which will include intensive one­-on­-one movement training sessions, behavioural strategies to increase patient motivation, and a task ­specific home exercise program using a hand splint. Participants in the 'control group' will be recruited from the same centre and will receive usual rehabilitation.

Outcomes will be assessed at baseline, post­ intervention, and at 3 months following the conclusion of intervention and will include assessment of range of movement, dexterity, functional task performance, and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33653 0
A/Prof Natasha Lannin
Address 33653 0
Occupational Therapy Department
The Alfred
55 Commercial Road
Prahran Victoria, Australia 3004
Country 33653 0
Australia
Phone 33653 0
+61 41 7135153
Fax 33653 0
Email 33653 0
[email protected]
Contact person for public queries
Name 16900 0
A/Prof Natasha Lannin
Address 16900 0
Occupational Therapy Department, The Alfred, 55 Commercial Road, Melbourne Vic 3004
Country 16900 0
Australia
Phone 16900 0
(+61) 03 90763230
Fax 16900 0
(+61) 0390762920
Email 16900 0
[email protected]
Contact person for scientific queries
Name 7828 0
A/Prof A/Professor Natasha Lannin PhD
Address 7828 0
Occupational Therapy Department, The Alfred, 55 Commercial Road, Melbourne Vic 3004
Country 7828 0
Australia
Phone 7828 0
(+61) 03 90763230
Fax 7828 0
(+61) 0390762920
Email 7828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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