| CTRI Number |
CTRI/2025/07/091652 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EXPERIMENTAL] |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out whether regular therapy with special task based exercise or brunnstorms therapy which helps stroke survivors regain better hand movement |
|
Scientific Title of Study
|
A comparative study on the effectiveness of task oriented training v/s brunnstroms approach with conventional therapy in hand rehab post stroke patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshika Mittal |
| Designation |
Post Graduate student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
OPD 1,Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
9058087576 |
| Fax |
|
| Email |
anshikamittal2799@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Sharda Sharma |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
OPD 1,Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
8630382470 |
| Fax |
|
| Email |
shardasharmaphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof DrNiraj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
OPD 1,Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun UTTARANCHAL 248001 India |
| Phone |
9997516613 |
| Fax |
|
| Email |
nirajkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anshika Mittal |
| Address |
OPD 1, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Prof Dr Sharda Sharma |
SHRI MAHANT INDIRESH HOSPITAL |
OPD 1,Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun Dehradun UTTARANCHAL |
8630382470
shardasharma.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe(IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The Brunnstrom Approach |
The Brunnstrom Approach, developed by physical
therapist Signe Brunnstrom, is a widely used neuro-rehabilitation technique
specifically designed to help stroke patients regain motor control by working through
distinct stages of recovery |
| Intervention |
Task-oriented approach |
Task-oriented approach- This approach is based on the idea that rehabilitation
is most effective when it directly targets the skills and movements a person needs to
perform real-life activities. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants with having difficulty in Hand function Post Stroke.
2. Participants with age group between 35-70yrs.
3. Participants will be taken only from SMIH Physiotherapy OPD and SMIH Neuro OPD |
|
| ExclusionCriteria |
| Details |
1.Aphasia
2.Conditions like fractures, joint deformities, or severe arthritis that limit movement independtly of stroke
3.Epileptic patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl meyer assessment for wrist and hand, Brunnstroms recovery stage of the hand |
alternative days for 8 weeks
treatment duration : 45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
04/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Group A receives Task-Oriented Training exercises with
Conventional Therapy By performing simple activities of daily living such as eating (using a cup and spoon),
dressing (wearing and taking off a shirt), using a belt, personal hygiene (using a towel ,
combing, tooth brushing) and other activities using household materials like bottle, book
etc.
Each of these activities will perform for 5 repetitions.
Tasks will be perform with the participants seating in front of the table placed at a suitable
height where objects related to the intervention are arranged.
The level of difficulty to the patient will increase slowly day by day by assigning the tasks
above the patient’s capacity and by increase the distance between the object by which task
should be carried out and reducing the size of the object and by decreasing the time to
carry out a task.
A rest interval of 5mins will be given whenever it is required by the patient in one exercise
period.
Along with task-oriented therapy, conventional therapy sessions will be conducted to the
patient’s which consisted of passive and active assisted mobilization of the upper limbs;
exercises with resistance or assistance from balls, elastic bands and dumbbells; active
assisted mobility exercises of the upper limb and fingers in a sitting position; moving
objects horizontally on a table; elevation and superposition of objects in the vertical plane;
and biomechanical tasks that simulated flexion–extension and abduction–adduction of the
shoulder and flexion–extension of the wrist and fingers. Group B receives Brunnstrom Movement Therapy with
Conventional Therapy 1. Imitation Synkinesis - Performance of difficult movements by performing the same
movement on the unaffected side 2. Proximal traction response - A stretch of the flexor muscles of one of the joints of
upper limb evokes or facilitates contraction of flexor muscles of all the other joints
resulting in a total shortening of the limb 3. Wrist fixation for Grasp
a. Synergy influence on wrist muscles, using synergy in both flexors and extensors
b. Wrist Functioning Position the wrist in extension. Resist active extension movements at
the proximal portion of the patient’s arm or to his closed fist.
c. Activation of wrist extensor muscles
Stabilize the wrist in extension. Stimulate the extensor carpi radialis longus as it crosses the
wrist joint. While applying percussion over the proximal portion of the wrist extensor
muscles, simultaneously ask the patient to squeeze. When squeezing, wrist support is
withdrawn and the patient is asked to hold the contraction. Provide repeated percussion
movements.
d. Wrist stabilization for grasp, elbow flexed. Repeat the entire process with the elbow
slightly flexed.
e. Hyperactive wrist extensor muscles.
In exceptional cases, practice relaxation by flexing the elbow. 4. Release of grasp and elicitation of extensor reflexes
a. Patient and therapist sit facing each other. Thumb is pulled out of the palm by a grip
around the muscles of the thenar eminence, and the forearm is supinate passively.
b. Supinate and pronate the forearm slowly. The movement is repeated to emphasize
supination. Cutaneous stimulation over the dorsum of the wrist and hand is given to the
supinated forearm.
c. Swatting of the fingers -Therapist uses a free hand for rapid, distally directed
movements over the proximal phalanges of the patient’s affected hand.
d. Eliciting stretch reflexes in the finger extensor muscles.
Along with Brunnstrom therapy, conventional therapy sessions will be conducted. |