| CTRI Number |
CTRI/2022/11/047617 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of task training in patients with stroke for hand rehabilitation. |
|
Scientific Title of Study
|
Effect of functional task-oriented training on upper limb function and quality of life in acute stroke patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jahanvi Desai |
| Designation |
post graduate student |
| Affiliation |
SVKM NMIMS, Sunandan Divatia School of Science. |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w)
Bhaktivedanta Road
Sunandan Divatia School of Science, Vile Parle West.
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
07069811769 |
| Fax |
|
| Email |
jahanvi.desai10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sabah Thaver |
| Designation |
assistant professor |
| Affiliation |
SVKMs NMIMS- Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Vile Parle West.
Bhaktivedanta Road
Sunandan Divatia School of Science, Vile Parle West.
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
|
| Fax |
|
| Email |
Sabah.Thaver@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jahanvi Desai |
| Designation |
post graduate student |
| Affiliation |
SVKM NMIMS, Sunandan Divatia School of Science. |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(w)
Bhaktivedanta Road
Sunandan Divatia School of Science, Vile Parle West.
Bhaktivedanta Road
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
07069811769 |
| Fax |
|
| Email |
jahanvi.desai10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital, SV Road, Vile Parle West, Mumbai 400056 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ali Irani |
Department of Physiotherapy,Nanavati super speciality hospital |
Department of Physiotherapy,Ground floor Nanavati super speciality hospital SV road ,vile parle(w)
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr Balabhai Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
conventional physiotherapy consists of two week protocol containing range of motion, upper limb and grip strengthening, and proprioceptive neuromuscular facilitation. total 12 sessions will be taken over 2 weeks. |
| Intervention |
functional task-oriented training |
functional task-oriented training consists of two week protocol based on daily functional activities for upper limb. Total 12 sessions will be taken over 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult stroke patients
Acute stroke patients with minimum activation of shoulder abductors and digit extensors.
Stroke patients with intact cognition and optimum level of arousal. |
|
| ExclusionCriteria |
| Details |
Any other neurological or musculoskeletal condition that would interfere with upper limb rehabilitation.
Patients with perceptual, visuospatial deficits or apraxia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Chedoke arm and hand activity inventory- version 9
Stroke specific quality of life |
Chedoke arm and hand activity inventory for upperlimb function at baseline and 2 weeks of the study.
Stroke specific quality of life for quality of life at 2 weeks and 8 weeks of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: Stroke refers to a neurological disorder caused by cerebrovascular
injury i.e., there might be blockage or burst of a brain vessel. After
stroke many individuals have difficulty using their affected upper
limb for activities of daily living (ADLs).In acute stroke the patient has
not learned to not use the affected extremity
as well as no compensatory strategies are learned. Therefore early
rehabilitation is important.. Recovery after stroke occurs mainly on the
basis of Neuroplasticity is the method in which the brain produce new neurons and set down new
connections between neurons. Neuroplasticity is achieved by
repetitive and active movements. Functional task-oriented training, is repetition of activities
mimicking activities of daily life. therefore may be helpful in recovery of upper limb function in acute stroke patient.AIM: To assess the effects of
functional task-oriented training on upper limb function and quality of life in
acute stroke patients. OBJECTIVES:1.To assess the effects of
conventional exercise on upper limb function and quality of life in acute
stroke patients.
2.To assess the effects of
functional task oriented training on
upper limb function and quality of life in acute stroke patients.
3.To compare the results of both
the groupsINCLUSION CRITERIA:1.Adult stroke patients
2.Acute stroke patients with minimum
activation of shoulder abductors and digit extensors.
3.Stroke patients with intact
cognition and optimum level of arousal.
EXCLUSION CRITERIA:1.Any other neurological or
musculoskeletal condition that would interfere with upper limb rehabilitation.
2.Patients with perceptual,
visuospatial deficits or apraxia. OUTCOME MEASURE: 1.Chedoke arm and hand activity inventory-
version 9 2. Stroke specific quality of life scale. |