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

10 Sep 2020

The date of last modification

Sep 10, 2020



Application Summary


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)


Trial Details


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

  1. Patients with stroke admitted to Teaching Hospital Karapitiya with a history of stroke with disability including of either hand.
  2. Onset of stroke within three weeks.
  3. Age above 22 year and below 60 years.
  4. Level of consciousness 15/15 in Glasgow Coma Scale.
  5. Modified Rankin scale of three or less in a scale of 0- 6 (0 = no disability, 6 = death).

Exclusion criteria

  1. History of previous stroke affecting the right upper limb.
  2. Dysfunction of the affected hand due to other illnesses like polyarthritis, carpal tunnel syndrome or nerve palsies, peripheral neuropathy.
  3. Difficulties in communication due to comprehensive or expressive aphasia.
  4. Inability understand the instructions.
  5. Known allergy to the electrode paste or skin cleaners.
  6. Those who withdraw the consent.
  7. Those who cannot attend the regular follow up visits due to logistical, financial or social reasons.
  8. Those who follow alternative rehabilitation therapies in addition to what is prescribed by the caring team of Teaching Hospital, Galle.
  9. Patients with other comorbities preventing them from participating in the research.
  10. Previous implant of pacemaker of any kind or any device that can be interfered with electrical signals.


Primary outcome(s)

1.

Improvement of mean scores of the following:
• Fugl-Meyer Scoring Upper Extremity (FMA-UE) - components such as motor functioning, sensory functioning, passive joint motion and joint pain will be assessed, • Bunnstrome staging (stage of recovery of a stroke patient), • Activities of Daily Living (ADL) according to Barthel Index

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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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