| CTRI Number |
CTRI/2026/02/103325 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Blood Flow Restriction on hand grip strength, pinch strength and dexterity in patients with stroke- an experimental study |
|
Scientific Title of Study
|
Effect of Blood Flow Restriction on hand grip strength, pinch strength and dexterity in patients with stroke- an experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjiv Kumar |
| Designation |
Head of Department, Department of Neurophysiotherapy |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Institute of Physiotherapy
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kajol Pandey |
| Designation |
Post Graduate Student |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Institute of Physiotherapy
Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
kajolpandey1804@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjiv Kumar |
| Designation |
Head of Department, Department of Neurophysiotherapy |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Institute of Physiotherapy
Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kajol Pandey |
| Address |
KLE INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR, BELAGAVI |
| Type of Sponsor |
Other [Self sponsor ] |
|
|
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 Sanjiv Kumar |
KLES Hospital and MECH |
Physiotherapy Department
Belgaum
KARNATAKA |
9448745648
sanjiv3303@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITTEE KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Flow Restriction Therapy |
Placement of the cuff: Proximal portion of the affected arm, just below the delotoid
Cuff width: 9-13 cm
Occlusion pressure: 40-50% of the limb occlusion pressure
Exercises: Hand gripping with therapy ball, pinch strengthening with putty, hand dexterity using pegboard
Duration: 30-40 minutes
Frequency: 3 times/week for 4 weeks |
| Comparator Agent |
Not Applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate, more than 18 years of age and all genders
Sollerman hand function less than 65
Post stroke cases with spastic hand (Brunnstrom stage more than 3 or within 18 months of stroke)
Able to comprehend commands |
|
| ExclusionCriteria |
| Details |
Uncontrolled hypertension, diabetes, peripheral vascular diseases
Patients with orthopaedic and neurological conditions which may affect the hand and hand grip, pinch and dexterity.
Patient on anti coagulants
Infections or open wounds
History of seizures
Bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand held dynamometer for grip strength
Pinch gauge for pinch strength
Purdue pegboard for hand dexterity |
At the baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fugl Meyer Assessment for the Upper Limb for motor recovery post stroke |
At the baseline and post the intervention |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
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)
|
16/02/2026 |
| 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="1"
Months="0"
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
|
This research protocol, titled "Effect of Blood Flow Restriction on Hand Grip Strength, Pinch Strength and Dexterity in Patients with Stroke," is an experimental study designed to evaluate the impact of low-load vascular occlusion training on upper limb recovery. Study Overview The study investigates Blood Flow Restriction Training (BFRT) as a rehabilitative tool for stroke survivors who may not tolerate traditional high-resistance exercises. * Target Population: Stroke patients aged >18 years with a spastic hand (Brunnstrom stage >3) and Sollerman hand function score <65. * Sample Size: 13 participants, determined using a 10% drop-off rate calculation. * Setting: Tertiary Care Hospital, Belagavi. * Study Design: Pre-post experimental evaluation over a 6-month duration. Methodology & Intervention The protocol employs a specialized tourniquet system to partially restrict arterial flow and fully block venous return during functional tasks. * BFR Parameters: A 9–13 cm cuff is placed on the proximal affected arm, inflated to 40–50% of the limb occlusion pressure. * Exercises: Hand gripping with a therapy ball, pinch strengthening with putty, and hand dexterity tasks using a pegboard. * Dose: 30–40 minutes per session, 3 times per week for a total of 4 weeks. * Safety: The cuff is deflated for 1–2 minutes between different exercises to allow for partial recovery. Outcome Measures * Primary: Hand grip strength (Jamar Hand Dynamometer), pinch strength (pinch gauge), and hand dexterity (Purdue Pegboard). * Secondary: Motor recovery assessed via the Fugl-Meyer Assessment-Upper Limb (FMA-UL). |