CTRI Number |
CTRI/2025/06/088492 [Registered on: 10/06/2025] Trial Registered Prospectively |
Last Modified On: |
09/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of task-oriented exercise on arm and hand function in neurological deficit patients: a randomized trial. |
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of task oriented exercise on arm and hand functions among patients with neurological deficit admitted at selected tertiary care hospitals of Western Maharashtra.
|
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saranya Chandran R |
Designation |
PG Trainee |
Affiliation |
College of Nursing AFMC Pune |
Address |
First Year MSc Nursing Trainee officer, Department of Medical Surgical Nursing, Division - Neurology Nursing , Room No:09 College of Nursing, Armed Forces medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
8547406780 |
Fax |
|
Email |
saranyachandru0000@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Mrs Tulika De Biswas |
Designation |
Assistant Professor |
Affiliation |
College of Nursing AFMC Pune |
Address |
Department of Medical Surgical Nursing, Division - Neurology Nursing, Room No-09 College of Nursing, Armed Forces medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
9874243204 |
Fax |
|
Email |
tulikadebiswas@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Mrs Saranya Chandran R |
Designation |
Saranya Chandran R |
Affiliation |
College of Nursing AFMC Pune |
Address |
First Year MSc Nursing Trainee officer, Department of Medical Surgical Nursing, Division- Neurology Nursing,Room No-09 College of Nursing, Armed Forces Medical College, Pune
Pune MAHARASHTRA 411040 India |
Phone |
9874243204 |
Fax |
|
Email |
tulikadebiswas@yahoo.com |
|
Source of Monetary or Material Support
|
Command Hospital, Southern Command, CME Road, Wanowrie, Pune, Maharashtra 411040 |
|
Primary Sponsor
|
Name |
Saranya Chandran R |
Address |
College of Nursing Armed Forces Medical College Solapur Pune Highway Wanowrie Pune 411040 |
Type of Sponsor |
Other [Self funded] |
|
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 |
Ms Saranya Chandran R |
Command Hospital |
Neurology and Neuro surgery Department Command Hospital Southern Command Golibar Maidan Wanwadi Pune Pune MAHARASHTRA |
8547406780
saranyachandru0000@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Armed Forces Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G904||Autonomic dysreflexia, (2) ICD-10 Condition: G935||Compression of brain, (3) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (4) ICD-10 Condition: G24||Dystonia, (5) ICD-10 Condition: G900||Idiopathic peripheral autonomic neuropathy, (6) ICD-10 Condition: G938||Other specified disorders of brain, (7) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Standard therapy |
Neurologically deficit patients receives the standard treatment of physiotherapy as prescribed by the physician. |
Intervention |
Task Oriented Exercises |
Task Oriented Exercises for arm and hand functions of neurologically deficit patient for the experimental group, which includes
open a jar of coffee,
call 911 in dial phone,
draw a line with a ruler,
pour a glass of water,
wring out washcloth,
do up 5 buttons of a shirt and
dry back with towel
These will be performed by the participants under the supervision of the researcher once daily for 30 minutes for a period of 5 days and thereafter will be asked to continue the intervention under the supervision of a caregiver which will be reinforce through daily phone calls by the investigator and by maintaining daily diary until 02 weeks.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Patients with neurological deficit who are:
more than 18 years,
having Chedoke Arm and Hand Activity Inventory score 20 or above (mild to moderate arm and hand dysfunction)
|
|
ExclusionCriteria |
Details |
Patients with neurological deficit who are:
not able to comprehend
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
the efficacy of task oriented exercises in terms of arm and hand function score. |
2 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/09/2025 |
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 Applicable |
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
|
This randomized control trial aims to evaluate the effective ness of task oriented exercises on arm and hand functions of neurologically deficit patients at selected tertiary care hospitals of Western Maharashtra. A total of 60 patients with neurological deficit will be recruited for the study using systematic random sampling. Participants will be randomly allocated into control and intervention group with 30 patients in each group. The intervention group will receive task oriented exercises which will be performed under the supervision of the researcher once daily for 30 minutes for a period of 5 days and thereafter will be asked to continue the intervention under the supervision of a caregiver which will be reinforce through daily phone calls by the investigator and by maintaining daily diary until 02 weeks. The control group will receive standard physiotherapy alone. Arm and hand function will assessed before and after the intervention by using CAHAI ( Chedoke Arm and Hand Activity Inventory)-7. The study aims to evaluate the effectiveness of task oriented exercises on arm and hand functions among patients with neurological deficit and also to associate the outcomes with selected socio demographic variables. This research will provide evidence on the effectiveness of task oriented exercises as supportive therapy along with physiotherapy for the patient with neurological deficit. |