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CTRI Number  CTRI/2025/07/090377 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can Intensive Arm Training and Brain Retraining Improve Hand Function and Daily Life for Stroke Survivors 
Scientific Title of Study   Impact of combining high-dose high-intensity upper limb training with motor learning techniques on improving hand functions and overall quality of life in individuals with chronic stroke. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirav P Vaghela 
Designation  Professor & Guide 
Affiliation  K. M. Patel Institute of Physiotherapy Bhaikaka University  
Address  Shree Krishna Hospital K M Patel institute of physiotherapy OPD no. 152 Karamsad Anand Gujarat India 388325

Anand
GUJARAT
388325
India 
Phone  9428647304  
Fax    
Email  niravpv@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Ajay O Pandey 
Designation  Incharge Principal 
Affiliation  Kasturba Gandhi Physiotherapy College 
Address  Kasturba Gandhi Physiotherapy College Mayur Park Nr Bhagat Petrol Pump Naroda Patiya Naroda

Ahmadabad
GUJARAT
382340
India 
Phone  9662018159  
Fax    
Email  aopandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ajay O Pandey 
Designation  Incharge Principal 
Affiliation  Kasturba Gandhi Physiotherapy College 
Address  Kasturba Gandhi Physiotherapy College Mayur Park Nr Bhagat Petrol Pump Naroda Patiya Naroda

Ahmadabad
GUJARAT
382340
India 
Phone  9662018159  
Fax    
Email  aopandey@gmail.com  
 
Source of Monetary or Material Support  
Aoura Physiotherapy Clinic 18, Pushkar Annexe Nr. Devi Cinema Naroda Bethak Naroda-382330 
Phsiotherapy OPD K.M. Patel Institute of Physiotherapy Shri Krishna Hospital Gokalnagar Karamsad 388325 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirav P Vaghela  Aoura Physiotherapy Clinic  Physiotherapy Department, Neurology Division, Room No. 18, Pushkar Annexxe Nr Devi Multiple Naroda Road, Bethak
Ahmadabad
GUJARAT 		 9428647304

niravpv@charutarhealth.org 
Dr Nirav P Vaghela  K M Patel Institute of Physiotherapy  Shree Krishna Hospital, Physiotherapy Department, Neurology Division, OPD no. 152, Karamsad, Anand, Gujarat, India 388325
Anand
GUJARAT 		 9428647304

niravpv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee-2, Bhaikaka University  Approved 
Institutional Ethics Committee-2, Bhaikaka University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G819||Hemiplegia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High-dose, high-intensity upper limb training (INTERVENTION GROUP)  A FITT-based exercise prescription tailored for individuals with CVA according to ACSM guidelines will be given to the intervention group. This group will receive a combination of high-dose, high-intensity upper limb training sessions that combine motor learning strategies for two hours per day, five days per week, for a total of 40 hours over the course of four weeks. Programs and progressions for exercises are to be followed. The participants will also be asked to increase their aerobic capacity for an hour each day on the two days off by using a recumbent seated cycle, cycle-ergometry, or a treadmill. The previously described treatment will be given for four weeks to get the intended results.  
Comparator Agent  Standard Rehabilitation Therapy (CONTROL GROUP)  The control group will get standard rehabilitation therapy for the same four weeks, which includes passive motions and stretches of the scapulothoracic joint, shoulder girdle, elbow joint, wrist joint and finger joints. After being discharged, the participants will have to self-continue their activities at home for an extra two weeks. The participants will receive notification when their involvement in the study is concluded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  a) A first-ever unilateral stroke (ischaemic or haemorrhagic) as defined by WHO, at least 6-months previously.
b) Moderate upper limb impairment as defined by Fugyl-Meyer Assessment - Upper Extremity (Woodbury et al., 2007) score between 19-46 (to avoid ceiling and floor effects)
c) Trace of muscle contraction in wrist extensor. Max 4 on the (Medical RCS) for shoulder elevation and elbow flexion/extension.
d) Ability to follow 2 step commands.
 
 
ExclusionCriteria 
Details  a) Other neurological diagnoses.
b) Serious cognitive impairment.
c) Increased muscle tone in wrist/finger extensors.
d) Orthopaedic Impairment or Visual disorder limiting the treatment.
e) Unable to give informed consent form.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fugyl-Meyer Assessment- Upper Extremity (FMA-UE)  Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups. 
 
Secondary Outcome  
Outcome  TimePoints 
Action Research Arm Test (ARAT)  Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups. 
Jebsen-Taylor Hand Function Test (JTHFT)  Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups 
Stroke-Specific Quality of Life Scale (SS-QOL)  Data will be collected at baseline (T0), post-intervention (T1) at 4 weeks, and follow-up time points after 6 weeks (T2) in both groups. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   17/07/2025 
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="2"
Months="0"
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  

Title: Impact of combining high-dose, high-intensity upper limb training with motor learning techniques on improving hand functions and overall quality of life in individuals with chronic stroke.

Background: Stroke incidence in India is high (1.44–1.66 million new cases annually), with 86.5 deaths per 100,000 yearly. Over 90% of survivors experience upper limb motor dysfunction, leading to long-term disability—66% remain dependent on daily activities five years post-stroke. Current rehabilitation focuses on lower limbs, while upper limb recovery plateaus after three months due to insufficient therapy intensity and limited integration of motor learning strategies.

Objectives:
1. Assess the impact of high-dose, high-intensity upper limb training combined with motor learning techniques on Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Action Research Arm Test (ARAT) and Jebsen-Taylor Hand Function Test (JTHFT)
2. Reduce upper limb impairments (Modified Ashworth Scale, range of motion).
3. Enhance quality of life (Stroke-Specific Quality of Life Scale, SS-QOL).
4. Investigate associations between age, sex, stroke laterality (dominant/non-dominant), and recovery.
5. Evaluate maintenance of benefits at 6-week follow-up.

Methods:

  • Design: Randomized controlled trial (70 participants, 35 per group).

  • Population: Chronic stroke patients (>3 months post-stroke) with upper limb impairment.

  • Intervention Group: 4-week protocol: 2 hours/day, 5 days/week (40 total hours) of high dose, high-intensity upper limb training + motor learning strategies (task-specific practice, feedback). Adjunct: Aerobic exercise (1 hour/day, 2 days/week). FITT-based: Tailored to ACSM guidelines for stroke.

  • Control Group: Standard rehabilitation (passive stretches, joint mobilizations).

  • Outcome Measures: Baseline, post-intervention (4 weeks), and follow-up (6 weeks) assessments of FMA-UE, ARAT, JTHFT, and SS-QOL


Significance: This trial addresses the critical gap in upper limb rehabilitation by combining high-dose training (time/repetitions) with motor learning techniques to promote neuroplasticity and functional recovery in chronic stroke. It challenges the post-3-month recovery plateau and aims to establish a scalable, evidence-based protocol for improving hand function, independence, and quality of life. Results may form clinical guidelines for aggressive, integrated upper limb rehabilitation in resource-limited settings.

Innovation: First study in India to integrate high-dose training (40 hours) with motor learning strategies in chronic stroke, targeting long-term functional gains and quality of life.

 
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