Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001283460
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
12/09/2016
Date last updated
11/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: a randomized controlled trial
Scientific title
The efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: a randomized controlled trial
Secondary ID [1] 289760 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hemiparesis 299618 0
gait limitations 299619 0
gait assymetry 299620 0
body balance 299621 0
stroke 299622 0
Condition category
Condition code
Stroke 299582 299582 0 0
Ischaemic
Physical Medicine / Rehabilitation 299583 299583 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted with selected stroke patients in subacute period previously treated in the Rehabilitation Clinic.
Participants who meet eligibility requirements will be randomly divided into the control and the study group. Study group patients will be enrolled in treadmill training with partial body weight support (PBWS) and real time visual feedback. The treadmill software displays a real time visualization of patient’s feet placement and the area in which the next step should be placed to maintain the symmetry of patient’s gait. The gait velocity and the required step length will be adjusted to the patient’s physical abilities. The amount of body weight support will not exceed 30% of the patient’s body weight. The control group members will be trained on the same treadmill with exactly the same body weight support system.
Treadmill training in both groups will be conducted by a physiotherapist who is not participating neither in a basic survey nor in a control test. Training parameters for each patient will be individually tailored by the physiotherapist. Participation in the training is confirmed in medical records.
Both group’s sessions will be conducted Monday to Friday ( 5 days) for 3 weeks. Each session will last 30 minutes.
Patients will implement a standard rehabilitation program but no other equipment as Lokomat or exoskeleton Ekso GT. Standard program is sent by rehabilitation team and is not administered as part of this study
All patients qualified for the study will practice on the treadmill as well as participate in the rehabilitation program set up by a physiotherapist’s team.
Each patient will train for a maximum 90 minutes a day. Patients will be assessed before and after treadmill gait training. Patients will stay in Rehabilitation Clinic for 5 to 7 weeks. All exercises including treadmill trainings will be prepared by the experienced physiotherapists, working in the Rehabilitation Clinic.
Intervention code [1] 295410 0
Treatment: Devices
Intervention code [2] 295411 0
Rehabilitation
Comparator / control treatment
Members of the control group will undergo the training on the same treadmill with exactly the same PBWS system as the study group. The control group will not be provided with the visual feedback software. The gait speed will be adjusted to the patient’s individual abilities. The amount of body weight support will not exceed 30% of patient’s body weight. Treadmill gait training time- 30 minutes. Number of trainings- 15, 3 weeks (form Monday to Friday). Alongside the treadmill training, the control group will also undergo a daily rehabilitation program, including 90 minutes of excersise therapy. Patients will stay in Rehabilitation Clinic from 5 to 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 299058 0
Temporal and spatial parameters of gait assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)
Timepoint [1] 299058 0
Baseline, after 3 weeks of treatment
Primary outcome [2] 299550 0
Kinematic parameters of gait assessed by 3D motion analysis system (BTS Smart, BTS Bioengineering, Milan, Italy)
Timepoint [2] 299550 0
Baseline, after 3 weeks of treatment
Primary outcome [3] 299551 0
Changes in gait symmetry ratio. The symmetry ratio will be calculated on the basis of analysis of the kinematic, temporal and spatial gait parameters for the right and left lower limb. A symmetry ratio will be calculated for all analyzed parameters. The left and right average values of swing time and stance time, step length, total hip and knee range of motion and intra-limb ratio of swing: stance time (SW/ST) a ratio with the largest value in the numerator so that all values for every individual were >1.0. A ratio value of 1.0 denotes perfect symmetry.
Timepoint [3] 299551 0
Baseline and after 3 weeks of treatment
Secondary outcome [1] 326045 0
Change in gait speed assessed in the 10 meter test.
Timepoint [1] 326045 0
Baseline, after 3 weeks of treatment
Secondary outcome [2] 326047 0
Change in muscular activity assessed by superficial EMG (Noraxon TELEMYO DTS,Noraxon U.S.A. Inc.)
Timepoint [2] 326047 0
Baseline, after 3 weeks of treatment
Secondary outcome [3] 326052 0
Change in functional capacity assessed using Barthel index
Timepoint [3] 326052 0
Baseline, after 3 weeks of treatment
Secondary outcome [4] 326866 0
Balance, assessed with postural sway on portable force plate (AMTI BP/OR). Analysed will be the length of the path of movement of COP (mm), the surface area of movement of COP (mm2), COP range scalar in anteroposterior (A-P) direction and COP range scalar in mediolateral (M-L) (mm) direction.
Timepoint [4] 326866 0
Baseline, after 3 weeks of treatment
Secondary outcome [5] 326867 0
Dynamic balance will be assessed by the Timed Up and Go Test
Timepoint [5] 326867 0
Baseline, after 3 weeks of treatment

Eligibility
Key inclusion criteria
First-time ischemic stroke in subacute phase (less than 60 days from stroke)
Unilateral hemiplegia
Independent gait
Brunnstrom Motor Recovery Stage (leg) from 2 to 3 stages
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Second or another stroke incydent
severe heart insufficiency and uncontrolled arterial hypertension
cognitive disorders impairing the understanding of and ability to follow instructions
visual field disturbances caused by a stroke or other visual disturbances impairing normal vision
orthopedic disorders significantly affecting the gait of participants
Untreated deep vein thrombosis

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/02/2016
Date of last participant enrolment
Anticipated
30/12/2016
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 8051 0
Poland
State/province [1] 8051 0
Podkarpackie

Funding & Sponsors
Funding source category [1] 294147 0
University
Name [1] 294147 0
University of Rzeszow
Country [1] 294147 0
Poland
Primary sponsor type
Individual
Name
Mariusz Druzbicki
Address
University of Rzeszow
Institute of Physiotherapy
Warszawaka 26a
25-305 Rzeszow
Country
Poland
Secondary sponsor category [1] 292977 0
None
Name [1] 292977 0
Address [1] 292977 0
Country [1] 292977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295558 0
The Ethical Committee of University of Rzeszow
Ethics committee address [1] 295558 0
Medical Faculty
Al. mjr. W. Kopisto 2 a
35-310 Rzeszow
Ethics committee country [1] 295558 0
Poland
Date submitted for ethics approval [1] 295558 0
02/11/2015
Approval date [1] 295558 0
02/02/2016
Ethics approval number [1] 295558 0
17/02/2016

Summary
Brief summary
Brain strokes are one of the main causes of permanent impairment. The main symptoms of stroke are hemiparesis, muscle tension disorders, balance and coordination impairment, cognitive functions and communicative disorders. Restoration of patient’s gait is one of the primary targets of rehabilitation after stroke. Although 80% of stroke survivors regain the ability of independent walking, their gait is often impaired and limited. Disorders mainly lower the gait speed and the covered distance, they also affect the stability of gait. Among many patients the asymmetrical walking pattern is observed among time and space-related parameters. In rehabilitation of stroke patients many different techniques and devices are used, treadmills, partial body weight support systems and robots are commonly used. The efficacy of gait training is increased in systems providing real time feedback (gait parameters), the method using acoustic and visual feedback is very efficient and important. The use of treadmill and PBWS facilitates patient’s moves, it also facilitates to perform a full gait cycle (similar pattern to the natural one) by patient, it allows to increase the gait speed, covered distance, what increases the efficacy of motoric training. The real time, visual feedback about the symmetry and the length of patient’s step allows him to adjust his gate properly and learn the symmetrical walking pattern.
The aim of this study is to asses the gait training with PBWS treadmill and visual feedback among patients during subacute period after stroke. The assumed hypothesis is that gait training on a treadmill with PBWS and visual feedback facilitates the reconstruction of the symmetrical gait in comparison to patients training on a treadmill with PBWS, but without visual feedback.
The study will be conducted on the clinical rehabilitation ward of the Clinical Provincial Hospital in Rzeszów, Poland. Patients recruited for the study will be stroke survivors, that had suffered from brain stroke three weeks before they were recruited for the study. Gait training will be performed using the Gait Trainer 3 treadmill with partial body weight support system (provided by Biodex). The treadmill software enables a real time feedback, informing the patient about the placement of his feet and the correct area they should be placed in order to make the patient’s step length symmetrical.
Patients qualified for the study will be randomly divided into two groups. The study group will be training on a treadmill with real time visual feedback and the control group will use the same treadmill, but without visual feedback provided. Each patient is going to undergo the training every day (from Monday to Friday) for three weeks. One training session will last for 30 minutes.
Qualifications for the study will be performed by experienced physiotherapists. Initial and control examinations will be performed by the team member, who is not participating in patient’s training. Along the treadmill gait training, patients will be undergoing the rehabilitation program, set by the physiotherapeutic team.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67718 0
Dr Mariusz Druzbicki
Address 67718 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 67718 0
Poland
Phone 67718 0
+48178721941
Fax 67718 0
+48178721930
Email 67718 0
[email protected]
Contact person for public queries
Name 67719 0
Dr Mariusz Druzbicki
Address 67719 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 67719 0
Poland
Phone 67719 0
+48178721941
Fax 67719 0
+48178721930
Email 67719 0
[email protected]
Contact person for scientific queries
Name 67720 0
Dr Mariusz Druzbicki
Address 67720 0
University of Rzeszow
Institute of Physiotherapy
Warszawska st. 26a
35-205 Rzeszow
Country 67720 0
Poland
Phone 67720 0
+48178721941
Fax 67720 0
+48178721930
Email 67720 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe efficacy of gait training using a body weight support treadmill and visual biofeedback in patients with subacute stroke: A randomized controlled trial.2018https://dx.doi.org/10.1155/2018/3812602
N.B. These documents automatically identified may not have been verified by the study sponsor.