To compare effect of virtual reality alone with the combined effect of Virtual reality and modified constraint induced movement therapy on upper limb motor function in stroke
Design
Randomized Control Trial
Settings and conduct
Dar ul Rehmat medical complex, Charsadda. Single blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Ischemic stroke of MCA subjects suffering from stroke for at least 6 months
Both genders of age between 40 to 60 years
Having at least 10° of active extension of each MCP joint, IP joints of all the digits, and 10° wrist extension of the affected limb
Spasticity Grade 1 to 3 according to Modified Ashworth Scale
Exclusion criteria:
Patients with visual deficits
Patients not willing to use virtual reality or CIMT
Patients with cognitive disorders
Patients with upper limb contracture
Intervention groups
1. Group (I) Virtual reality
2. Group (II) Virtual reality combined with modified constraint induced movement therapy
Main outcome variables
Stroke
General information
Reason for update
Acronym
Upper limb motor function recovery in stroke
IRCT registration information
IRCT registration number:IRCT20210615051585N2
Registration date:2021-11-24, 1400/09/03
Registration timing:retrospective
Last update:2021-11-24, 1400/09/03
Update count:0
Registration date
2021-11-24, 1400/09/03
Registrant information
Name
Saima Gul
Name of organization / entity
Shifa Tameer - e - Millat University
Country
Pakistan
Phone
+92 51 8441751
Email address
saimagul.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-01, 1400/01/12
Expected recruitment end date
2021-05-01, 1400/02/11
Actual recruitment start date
2021-05-01, 1400/02/11
Actual recruitment end date
2021-07-01, 1400/04/10
Trial completion date
2021-08-01, 1400/05/10
Scientific title
Effect of Virtual Reality combined with modified Constraint-Induced Movement Therapy based upper limb training on chronic stroke survivors
Public title
Effect of Virtual Reality combined with modified Constraint-Induced Movement Therapy based upper limb training on chronic stroke survivors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic stroke of MCA subjects suffering from stroke for at least 6 months
Both genders of age between 40 to 60 years
Having at least 10° of active extension of each MCP joint, IP joints of all the digits, and 10° wrist extension of the affected limb
Spasticity Grade 1 to 3 according to Modified Ashworth Scale
Exclusion criteria:
Patients with visual deficits
Patients not willing to use virtual reality or CIMT
Patients with cognitive disorders
Patients with upper limb contracture
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment for treatment using sealed envelope
26 Sheets of properly cut Aluminum paper double the size of the paper. 26 Sheets of Carbon paper cut into appropriate size according to the paper used.
A standard-sized square paper was taken in which group "(VR)" was marked. In this way, 13 papers were prepared marked with "(VR)" and 13 square-shaped papers marked with "(VR+mCIMT)". The sheet of paper on which either (VR) or (VR+mCIMT) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (VR) or (VR+mCIMT)) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 13 envelops of "(VR)" and 13 envelops of "(VR+mCIMT)"were prepared. With a total number of 26 envelopes. These 26 envelopes were then thoroughly shuffled like a deck of cards.
The envelopes were then marked with numbers 1-26. Each participant picked the envelope in order from 1-26 and was given an intervention (VR or VR+mCIMT) accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant don’t know about in what group they are. Only the researcher doing the study knows which treatment or intervention the participant is receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital and Shifa
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
25000
Approval date
2021-04-01, 1400/01/12
Ethics committee reference number
IRB # 080-21
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Upper limb motor function
Timepoint
Baseline, 2nd week and 4th week after intervention
Method of measurement
Wolf motor function test
Secondary outcomes
1
Description
Spasticity
Timepoint
4th week
Method of measurement
Modified Ash worth scale
Intervention groups
1
Description
Virtual reality Group: Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The VR protocol included using VR headset and the games used were Rally ball and Reflex ridge. In the Rally ball game, balls approaching the player from multiple angles are hit from a chair. The Reflex Ridge game involves hitting, grasping obstacles while sitting in a chair. The patient played each game for 10-mins per session. Conventional therapy includes: passive stretching, repetitive task-specific activities, passive, active-assisted and active ROM exercises
Category
Rehabilitation
2
Description
Virtual reality combined with m-CIMT Group: Treatment for 20 min 3 sessions per week for 4 weeks along with the conventional therapy. The unaffected hand of participant was restrained and then the same VR treatment (as above) given to the participants.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dar ul Rehmat medical complex
Full name of responsible person
Dr Akmal khan
Street address
Main GT road, Charsadda
City
Charsadda
Postal code
25000
Phone
+92 91 5833853
Email
Drakmal24@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
44000
Phone
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Grant name
NONE
Grant code / Reference number
NONE
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shifa Tameer e Millat University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Islamabad
Postal code
44000
Phone
+92 51 8441751
Email
saimaa.gul@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Islamabad
Postal code
44000
Phone
+92 332 1964158
Email
saimaa.gul@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Islamabad
Postal code
44000
Phone
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD