Home » Trials » SLCTR/2020/019
Computer Assisted Rehabilitation in Improving Hand Function in Patients with Stroke
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SLCTR Registration Number
SLCTR/2020/019
Date of Registration
The date of last modification
Aug 26, 2022
Scientific Title of Trial
Computer Assisted Rehabilitation in Improving Hand Function in Patients with Stroke
Public Title of Trial
Outcome of hand function in patients receiving computer assisted physiotherapy in addition to conventional physiotherapy and functional electrical stimulation compared to conventional physiotherapy and functional electrical stimulation alone in patients with hand dysfunction due to stroke.
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
None
Public Acronym
None
Brief title
Brain Computer Interphase in stroke rehabilitation.
Universal Trial Number
U1111-1258-0817
Any other number(s) assigned to the trial and issuing authority
2020.P.050 (ERC: Faculty of Medicine, University of Ruhuna)
What is the research question being addressed?
Is Computer Assisted Rehabilitation superior to conventional physiotherapy or Functional Electrical Stimulation alone?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study Setting: Outpatient Rheumatology Clinic, Teaching Hospital, Karapitiya, Galle, Sri Lanka and Clinical Neuroscience Centre, Department of Medicine, Faculty of Medicine , University of Ruhuna, Galle.
Subjects will be assigned to the groups randomly using block randomization (block size of 12). One group will receive Brain Computer Interphase (BCI) with functional electrical stimulation (FES) in addition to standard therapy for 15 minutes per session and 3 sessions per week. The second group will receive FES in addition to standard therapy 15 minutes per session and 3 sessions per week. The control group will receive additional 15 minutes of standard therapy (physiotherapy) without any other intervention (30 minutes per session and 3 sessions per week).
Patients receiving FES and BCI have twice the duration of therapy which can have an impact on outcome. Hence the control group is also given the same duration as in the intervention group.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Improvement of mean scores of the following: Surface Electromyography (EMG) in completely paralyzed muscle will be evaluated before and after interventions (compare improvement of motor units recruited with attempted contraction) |
[ Timepoint: Before and 4, 8 and 12 weeks after intervention ] |
Secondary outcome(s)
|
1.
Improvement of ADLs according to Barthel Index |
[ Timepoint: Before and 12 weeks after interventions ] |
|
2.
Patient perception of quality of life according to WHOQoL (BREF) scale.This has 4 domains, physical, psychological, social relationships and environmental. |
[ Timepoint: Before and 12 weeks after interventions ] |
Target number/sample size
69 (23 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-11-01
Anticipated end date
2022-10-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Request for Funding from National Foundation of Science Sri Lanka and University of Ruhuna,
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2020-07-17
Approval number
2020.P.050 (19.05.2020)
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Ruhuna |
| Institutional Address: | Faculty of Medicine, University of Ruhuna, P O Box 70, Galle, Sri Lanka |
| Telephone: | +94912222314 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Kithsiri Pathirana
Senior Professor In Medicine & Consultant Neurologist
P.O Box 70,
Galle, Sri Lanka
Tel: +94912246881
Mob: +94777911741
Fax: +9491222314
kdp@med.ruh.ac.lk
Contact Person for Public Queries
Kithsiri Pathirana
Senior Professor In Medicine & Consultant Neurologist
P.O Box 70,
Galle, Sri Lanka
Tel: +94912246881
Mob: +94777911741
Fax: +9491222314
kdp@med.ruh.ac.lk
Primary study sponsor/organization
K D Pathirana
Senior Professor in Medicine
P. O Box 70, Galle,
Sri Lanka
Tel: +94777911741
Fax: +9491222314
kdp@med.ruh.ac.lk
Secondary study sponsor (If any)
Noelin W Prins
Senior Lecturer
Faculty of Engineering
University of Ruhuna
Hapugalla
Galle
Sri Lanka
0773889599
(94)0 91 2245762
prins@eie.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All data that underlie results in the publication will be shared (beginning 6 months and ending 36 months following article publication), with investigators whose proposed use of the data has been approved by an independent review committee (by their institution) identified for this purpose and have a study protocol in place. Data may be used for analysis or publishing to achieve aims in the approved proposal. Proposals should be directed to prins@eie.ruh.ac.lk or kdp@med.ruh.ac.lk to gain access. Individuals who request for data will need to sign a data access agreement. Personal Data of individual participants will not be shared under any condition due to privacy concerns. Study protocol, Informed Consent Form and statistical plan will also be available upon request by same reasoning and methods as the above data
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
