CTRI Number |
CTRI/2020/09/027651 [Registered on: 08/09/2020] Trial Registered Prospectively |
Last Modified On: |
01/07/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) Other (Specify) [PhD Thesis] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of a game-based exercise training to improve arm function in people with paralysis on one side of the body |
Scientific Title of Study
|
Effectiveness of an intensive, functional, gamified Rehabilitation program on upper limb motor function in people with stroke: A randomized clinical trial (EnteRtain Trial) |
Trial Acronym |
EnteRtain Trial |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sulfikar Ali A |
Designation |
PhD Scholar |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
Phone |
8714462433 |
Fax |
|
Email |
abdurahimpgdi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Senthil Kumaran D |
Designation |
Associate Professor |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
Phone |
9986910303 |
Fax |
|
Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Senthil Kumaran D |
Designation |
Associate Professor |
Affiliation |
Manipal College of Health Professions |
Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
Phone |
9986910303 |
Fax |
|
Email |
senthil.kumaran@manipal.edu |
|
Source of Monetary or Material Support
|
BeAble Health Pvt Ltd, IIT Hyderabad, Telangana, India |
|
Primary Sponsor
|
Name |
BeAble Health Pvt Ltd IIT Hyderabad Telangana India |
Address |
610, 6th Floor, Academic Block C, Center for Healthcare Entrepreneurship, Indian Institute of Technology – Hyderabad, Sangareddy, Telangana – 502285
|
Type of Sponsor |
Other [Private organization] |
|
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 |
Sulfikar Ali A |
Kasturba Hospital |
1st floor, N1 block, Department of Physiotherapy, Neurorehabilitation unit, Kasturba Hospital, Manipal Udupi KARNATAKA |
8714462433
abdurahimpgdi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
Aravind Eye Hospital Institutional Ethics Committee |
Approved |
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
Shrey Hospital Institutional Ethics Committee |
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 |
Intervention |
Intensive, functional gamified training |
Participants in the experimental group will receive an intensive, functional, gamified upper limb rehabilitation using the ArmAble™. The functional games include; Champion cleaner, Strike the mosquito, Delicious dosa, Roll the roti, Washing the vessels, Prayer (Indian Style), Door opening and closing, Ironing cloths, Pressing the switch, Counting the money, Hang up and take down clothes, Typing on mobile or computer, Lock opening with key, Filling the bucket with water and fun-based games includes Bounce the ball, Fresh fruit catcher, Sublime Sparrow, Body builder and Carefree Color. These games are controlled by the console through the shoulder, elbow, forearm and hand movements. Encouraging audio–visual cues by both the device and the therapist will be provided to the participant for maintaining the interest and motivation.
Participants enrolled to the experimental group will be made to sit in a relaxed position with trunk in midline, arm placed on the ArmAble™ platform with the elbow semi-flexed, the forearm pronated and the wrist in neutral position. Patient will be either asked to hold the gaming console or their hands will be positioned/secured with straps on the console of the device depending on their ability and will be asked to start the games. Then the Games will be selected depends on the participant’s preference, context and ability level. The gamified exercise training will be provided for a minimum of 45-60 min per day.
Adequate rest period will be provided between the rehabilitation if needed. In addition to this, participants will also receive the conventional therapy that includes passive and active mobilization of limbs, facilitatory/inhibitory techniques, muscle strengthening, balance and gait training for a minimum of 45-60 min. Participants in the intervention gruop will receive the training for a total duration of 2 hours/day, 6 days a week for a period of 2 weeks. After two weeks, participants will be advised to continue a home-based, functional upper limb rehabilitation program for a minimum of 30 min per day for six days a week for a period of four weeks.
|
Comparator Agent |
Intensive, functional task based training |
Participants allotted to the comparator group will receive an intensive, repetitive, task-oriented movements of the affected upper limb without ArmAble™ device under the supervision of the therapist. The training includes; Lifting the upper limb and placing on table, Reaching and placing the object, Pushing the chair with hand and move the chair forward, Mopping the table, Open fingers to hold a cup and move towards mouth, Pouring water from one cup to another, Opening and closing the door by bending the wrist, Tilting the plate up by bending the wrist. Minimum of 3 activities will be trained per day. Each activity will be performed for 100 times within 45 to 60 minutes. Encouraging audio–visual cues by the therapist will be provided to the participant for maintaining the interest and motivation. Participants allotted to the comparator group will receive intensive, repetitive, task-oriented movements of the affected upper limb for a minimum of 45-60 min. In addition to this, participants will also receive the conventional therapy that includes passive and active mobilization of limbs, facilitatory/inhibitory techniques, muscle strengthening, balance and gait training for a minimum of 45-60 min. Participants in the comparator gruop will recieve the training for a total duration of 2 hours/day, 6 days a week for a period of 2 weeks. After two weeks, participants will be advised to continue a home-based, functional upper limb rehabilitation program for a minimum of 30 min per day for six days a week for a period of four weeks. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
(1)diagnosed with unilateral stroke confirmed clinically and/or radiologically by a physician; (2) heamo-dynamically stable; (3) with a stroke severity score > 6 on NIHSS; (4)having a Brunnstorm voluntary control grade between 1-5 in the affected upper limb; (5) with a modified Ashworth scale score less than or equal to 3 in the affected upper limb;(6) having a Montreal Cognitive Assessment (MoCA) score more than or equal to 26 points; and (7) having the ability to sit with or without support. |
|
ExclusionCriteria |
Details |
(1) global or receptive aphasia; (2) major medical problems or co-morbidities that preclude their participation in the study (such as shoulder pain in the paretic limb, shoulder subluxation/dislocation, severe arthritis, or previous surgery with functional limitation); (3) complex regional pain syndrome; (4) functional vision and/or hearing loss limiting computer use; and (5) vestibular disorders |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Fugl-Meyer assessment- Upper Extremity Scale (FMA-UE)
Action Research Arm Test (ARAT) |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Motricity Index (MI)-arm component |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
Kinematic analysis |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
Visual analog fatigue scale (VAFS) |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
modified Rankin Handicap Scale (mRS) |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
Stroke impact scale (SIS) version 3.0 |
Pre-intervention (T0)
Post-intervention at 2 weeks (T1)
Follow up assessment at 6 weeks (T2) |
Game user experience satisfaction scale (GUESS) |
Post-intervention at 2 weeks (T1)
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
15/09/2020 |
Date of Study Completion (India) |
31/01/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Sulfikar Ali A, Arumugam A, Kumaran D S. Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial. Contemp Clin Trials. 2021 Apr 20;105:106381. doi: 10.1016/j.cct.2021.106381.
3.Ali AS, Kumaran DS, Unni A, Sardesai S, Prabhu V, Nirmal P, Pai AR, Guddattu V, Arumugam A. Effectiveness of an Intensive, Functional, and Gamified Rehabilitation Program on Upper Limb Function in People With Stroke (EnteRtain): A Multicenter Randomized Clinical Trial. Neurorehabil Neural Repair. 2024 Apr;38(4):243-256. doi: 10.1177/15459683231222921. Epub 2024 Jan 29. PMID: 38284559. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Stroke lead to a wide range of upper limb impairment, activity limitation and participation restriction. Effective way to improve upper limb function is characterized by early intensive functional repetitive training. However most of the people with stroke have insufficient movement post-stroke to perform the activities and are incapable of performing intensive functional repetitive task training, as well as repetitive nature of these practices will adversely impact on adherence. Therefore, the need of the hour in upper limb rehabilitation is an innovative intervention incorporating intensive, repetitive, functional task-oriented training that can be initiated early after stroke and is also cost effective, fun based and motivating. A new gaming device called ArmAbleâ„¢ which is a non-immersive, interactive arm rehabilitation device designed to enable and encourage upper limb function with minimal therapist assistance following stroke has been developed recently. Therapy using ArmAbleâ„¢ caters intensive, repetitive training from the very initial phase of stroke recovery and it is fun-based, motivating, challenging and provides feedback. The aim of this study is to determine the effectiveness of an intensive, functional, gamified rehabilitation program using ArmAbleâ„¢ compared to a conventional therapy program on upper limb motor function and activity in people with stroke. In this randomized, clinical, single blinded trial, a total number of 120 participants with acute/sub-acute stroke, aged between 18 and 80 years, of either gender will be included. An independent centralized stratified block randomization will be done and participants will be allocated to either experimental or comparator group. Randomization sequence will be generated by one of the investigators (SK) using a computer-generated random number table and computed in 20 permuted blocks of six participants each. Allocation concealment will be done by Sequentially Numbered Opaque Sealed Envelopes (SNOSE). Outcome assessors will be blinded to the group allocation. Stratification will be done based on age (<45 vs.>45 years), and severity of stroke (NIHSS score 5-14 (mild to moderately severe)/15-24 (severe)/>25 (very severe). Patients in the experimental group will receive intensive, functional, gamified upper limb rehabilitation provided using Arm Ableâ„¢ for a minimum of 45 min to 1 hour along with conventional therapy. Participants in the control group will receive intensive, repetitive task-oriented movements of the affected upper limb (for a minimum of 45 min to 1 hour) and conventional therapy (45 min to 1 hour). Participants in both groups will receive 12 sessions of therapy in 2 weeks. After two weeks, participants in the both the groups will be advised to continue a home-based, functional upper limb rehabilitation program for a minimum of 30 min per day for six days a week for a period of four weeks. Primary outcome measures: upper limb function (Fugl Meyer assessment for upper extremity) and activity (action research arm test) in people with stroke; secondary outcome measures: upper limb muscle strength (motricity index), movement quality of upper extremity reach in terms of distance and speed (movement performance analysis), fatigue (visual analog fatigue scale), activities of daily function (modified Rankin Scale), quality of life (stroke impact scale Version 3.0), and video game satisfaction (game user experience satisfaction scale). Measurements will be recorded at baseline, and following intervention at the end of 2nd and 6th week.
If found effective, functional gamified
rehabilitation provided through ArmAbleâ„¢ can be used from the acute and
sub-acute stages of stroke to make the therapy more intensive, repetitive,
motivating and fun based. |