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CTRI Number  CTRI/2024/08/072450 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
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   Intensive arm therapy for stroke recovery in low-resource settings: The HUTS trial 
Scientific Title of Study   High-intensity upper limb rehabilitation training in sub-acute stroke survivors in a low-resource setting: The HUTS trial - an RCT.  
Trial Acronym  HUTS  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananya Rakesh Sharma 
Designation  Physiotherapist  
Affiliation  St. Johns Medical College Hospital 
Address  Room no 66, Ground floor, Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  6363542916  
Fax    
Email  ananyarakeshsharma1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ananya Rakesh Sharma 
Designation  Physiotherapist  
Affiliation  St. Johns Medical College Hospital 
Address  Room no 66, Ground floor, Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  6363542916  
Fax    
Email  ananyarakeshsharma1994@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ananya Rakesh Sharma 
Designation  Physiotherapist  
Affiliation  St. Johns Medical College Hospital 
Address  Room no 66, Ground floor, Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka

Bangalore
KARNATAKA
560034
India 
Phone  6363542916  
Fax    
Email  ananyarakeshsharma1994@gmail.com  
 
Source of Monetary or Material Support  
St. Johns Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034. 
 
Primary Sponsor  
Name  Ananya Rakesh Sharma 
Address  Room no 66, Ground floor, 42, Neurology and neurosurgery unit, Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka Karnataka 560047 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ananya Rakesh Sharma  St. Johns Medical College Hospital  Room no 66, Ground floor, 42, Neurology/neurosurgery unit, Department of Physiotherapy, St. John’s Medical College Hospital, Sarjapur Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka
Bangalore
KARNATAKA 		 6363542916

ananyarakeshsharma1994@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St. Johns Medical College & Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active control, usual care  Patient will receive usual care of 60 mins/day of upper limb rehabilitation, out of which a 40 minute session/day will be done in direct supervision of the therapist and 20mins/day (1/3 of the total duration of the intervention) will be done by the caregiver under the guidance of the therapist. The treatment techniques and the intervention will be based on their Fugl Meyer Assessment upper extremity values, the therapist will receive guidance through a well-prepared manual which is the same for the intervention group.  
Intervention  High-intensity upper limb rehabilitation.  Patient will receive 180 mins/day of high-intensity upper limb rehabilitation, out of which 120mins/day will be done under direct supervision of the therapist. The 120mins/day will be divided into 60 mins of sessions with at least 20mins of gap between the two sessions. The last 60mins/day (1/3 of the total duration of the intervention) will be done by the caregiver under the guidance of the therapist. The treatment techniques and the intervention will be based on their Fugl Meyer Assessment upper extremity values, the therapist will receive guidance through a well-prepared manual which is the same for the active control group.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Subacute stroke survivors: more than 7 days and less than 6 months since the time of stroke.
2) Fugl Meyer score Upper extremity 0 to 44.
3) Montreal Cognitive Assessment with a score higher than 25 out of 30
 
 
ExclusionCriteria 
Details  1) Diagnosed with other neurological disorders.
2) Medically unstable.
3) The patient complains of shoulder pain with a numerical pain rating scale score equal to or higher than 7 during movement. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fugl Meyer Assessment Upper extremity.  Every week for 3 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Interviewing therapist, patient and their caregiver to understand the benefits and obstacles faced during the study protocol  Every week till 3 weeks.  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   30/08/2024 
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   This prospective, assessor-blinded RCT on subacute stroke survivors. The study aims to understand the effect of high-intensity, high-dose upper limb training compared to usual care. To overcome the main drawbacks of a low-resource setting (financial resources, manpower and time), the protocol involves caregivers in the intervention protocol to both train them and reduce the financial and manpower-related workload. The patients will be assigned to the intervention group or active control group in a 1:1 ratio. The intervention group will receive high-intensity upper limb training i.e. 180mins/day for 6 days/week for 3 weeks and the active-control group will receive 60mins/day for 6 days/week for 3 weeks. For both groups, caregivers will provide intervention for 1/3 of the total therapy time i.e. 60 minutes for the intervention group and 20 minutes for the active control group.  At baseline and every week till 3 weeks of intervention, the Fugl Meyer Assessment for Upper Extremity (FMA-UE) will be done for every participant.
The intervention protocol will be the same for both the intervention group and active-control group, the intervention group will receive a higher number of repetitions. The treating therapist will be provided with a manual and exercise video which will be the same for both groups, the only difference will be the dose and intensity. The exercises will be initiated according to the patient’s status and goal. For the caregiver training, the caregiver will be provided with a manual/videos or photos where the therapist will decide the exercises that have to be conducted bedside.  The caregiver will be explained in detail. The first two days of training will happen under the supervision of the therapist. After this, the therapist will review the exercises daily, progress the exercises accordingly and clear if any doubts arise. 
 
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