| CTRI Number |
CTRI/2025/05/087452 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the effect of Modified constraint induced movement therapy on recovery from one-sided neglect after Stroke |
|
Scientific Title of Study
|
Effect of modified Constraint induced movement therapy on hemineglect in acute stroke: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIDHI R KAMATH |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018,
India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8217636882 |
| Fax |
|
| Email |
kamathnidhi82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purosotham Chippala |
| Designation |
Professor |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018,
India.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purosotham Chippala |
| Designation |
Professor |
| Affiliation |
NITTE INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018,
India.
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala_puru@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Justice K S Hegde charitable hospital |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018,
India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nidhi R Kamath |
Justice K S Hegde charitable hospital. |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte,Mangaluru, Karnataka 575018,India.
Dakshina Kannada
KARNATAKA |
8217636882
kamathnidhi82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Nitte institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physical therapy |
Subjects in the control group will be receiving the conventional physical therapy
treatment which includes:
Positioning
Stretching and strengthening
Active and passive range of motion exercises
Strategies in improving patient’s ADLs
Bed mobility exercises: Rolling (Log roll, segmental rolling), Bridging, Supine to side
lying, side lying to sit, sitting supported, weight shifting and weight bearing, sit to
standing, standing, walking, balance training, coordination training and gait training.
PNF patterns (chopping movements, lifting patterns) on the affected side.
Conventional physical therapy will be given for 45 minutes per session per day for
7 to 8 days. |
| Intervention |
MODIFIED CONSTRAINT INDUCED MOVEMENT THERAPY |
Patients in experimental group will receive modified CIMT along with the
conventional therapy. The intervention will be delivered as following
1.Constraining the Unaffected upper-limb: The unaffected upper-limb is
constrained using a mitt or glove during the therapy sessions and additional 3 to
4 hours per da(during waking hours)
2.Intervention: The affected upper limb is used repeatedly in functional tasks. The
idea is to engage the paretic limb and increase his/her awareness on that
neglected limb as much as possible in repetitive tasks. Tasks shall include more
functional tasks (e.g., picking up objects, feeding, writing) that he/she would
routinely perform.
3. Shaping and Task Modification: For tasks where the patient has limited
capacity to perform, it is modified to match their abilities.
4. Behavioral Techniques: Positive reinforcement and motivational feedback are
incorporated to encourage the patient. visual scanning activities will be also
incorporated and Verbal instructions will be used to encourage the patient to turn
the head to the affected side to anchor his or her attention to that side of space.
Experimental group will receive about one session of modified CIMT for 30
minutes along with 45 minutes of conventional therapy per day with constraint of
unaffected upper-limb for 3 to 4 hours for 7 to 8 consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Post stroke patients who are willing to participate in the study
Acute stroke of non-dominant hemisphere confirmed by MRI or CT scan
Patients with Hemineglect
Hemiparesis with upper limb having at least 20 degree of wrist extension and 10
degree of finger extension.
Score greater than10 on Catherine Bergego scale
Able to follow and respond to visual and verbal instruction. |
|
| ExclusionCriteria |
| Details |
Not willing to give consent
Recurrent stroke with residual disability
Unconscious patients
Uncontrolled Diabetes Mellitus and Hypertension
Other neurological conditions
Aphasia
Cognitive impairment
Pre morbid or co-morbid impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Catherine Bergego Scale
Fugl-Meyer Assessment for upper extremity (FMA-UE) |
Outcomes will be assessed at 2 time points that is at baseline and after 7 to 8 days of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study investigates the impact of Modified Constraint Induced Movement Therapy (mCIMT) on patients suffering from hemineglect following an acute stroke. Hemineglect, typically resulting from right hemispheric strokes, is a neuropsychological condition where the patient fails to attend to the side of space opposite the brain lesion. It significantly hampers functional recovery and quality of life.The intervention group will receive Modified Constraint Induced Movement Therapy (mCIMT) in addition to conventional physiotherapy. mCIMT involves restricting the unaffected upper limb using a mitt or padded glove for 3 to 4 hours daily during waking hours. This is combined with structured, task-specific training sessions where the patient performs repetitive, functional activities using the affected arm. Tasks may include reaching, grasping, feeding, and writing—chosen to simulate daily life activities and promote awareness of the neglected side.The therapy is delivered in daily 30-minute sessions of mCIMT plus 45 minutes of conventional therapy over 7–8 consecutive days. The control group will receive only conventional therapy, including positioning, ROM exercises, strengthening, ADL training, and gait activities.The study uses two primary outcome measures to evaluate the effectiveness of the intervention. The **Catherine Bergego Scale (CBS)** assesses the severity of hemineglect by observing patients during daily activities, with scores ranging from 0 (no neglect) to 30 (severe neglect), and also captures the patient’s awareness of their condition (anosognosia). The **Fugl-Meyer Assessment for Upper Extremity (FMA-UE)** evaluates motor function, reflexes, and coordination of the affected upper limb through 33 items scored from 0 to 2, categorizing motor ability from poor to full capacity. Together, these tools provide a detailed picture of both functional and motor recovery in stroke patients.
|