CTRI

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CTRI Number

CTRI/2025/06/088222 [Registered on: 04/06/2025] Trial Registered Prospectively

Last Modified On:

21/05/2025

Post Graduate Thesis

No

Type of Trial

Interventional

Type of Study

Other (Specify) [technology-assisted, activity-based rehabilitation intervention]

Study Design

Single Arm Study

Public Title of Study

Game based therapy for improving hand function after spinal cord injury

Scientific Title of Study

Gamified Sensor-Based Upper Extremity Functional Rehabilitation in Individuals with Spinal Cord Injury: A Pilot Clinical Trial

Trial Acronym

GSBUEFR

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sunpreet Singh Hanspal
Designation	Occupational Therapist
Affiliation	Sri Balaji Action Medical Institute
Address	Spine And Rehabilitation Centre ,Room no 2 SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 Spine And Rehabilitation Centre, Room no 2 SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 West DELHI 110063 India
Phone	9711018421
Fax
Email	sunpreetsingh055@gamil.com

Details of Contact Person
Scientific Query

Name	Sunpreet Singh Hanspal
Designation	Occupational Therapist
Affiliation	Sri Balaji Action Medical Institute
Address	Spine And Rehabilitation Centre , Room no 2 SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 Spine And Rehabilitation Centre, Room no 2 SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 West DELHI 110063 India
Phone	9711018421
Fax
Email	sunpreetsingh055@gamil.com

Details of Contact Person
Public Query

Name	Sunpreet Singh Hanspal
Designation	Occupational Therapist
Affiliation	Sri Balaji Action Medical Institute
Address	Spine And Rehabilitation Centre, Room no 2 , SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 Spine And Rehabilitation Centre, Room no 2 SRI BALAJI ACTION MEDICAL INSTITUTE A - 4, Paschim Vihar, New Delhi - 110063 West DELHI 110063 India
Phone	9711018421
Fax
Email	sunpreetsingh055@gamil.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Sri Balaji Action Medical Institute
Address	A - 4, Paschim Vihar, New Delhi - 110063
Type of Sponsor	Research institution and hospital

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
Sunpreet Singh Hanspal	Sri Balaji Action Medical Institute	A 4 Paschim Vihar New Delhi India West DELHI	9711018421 sunpreetsingh055@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Sri Balaji Action Medical Institute (SBAMI), New Delhi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G95\|\|Other and unspecified diseases ofspinal cord,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Gamified Sensor-Based Upper Extremity Functional Rehabilitation	Intervention: Stage 1(Device Orientation) Patient will made to sit on a wheelchair with Belt(for safety) in front of a wooden table and LED screen of 55” Device/components will be explained Stage 2 (Gamified Sensor-Based therapy) Therapy Programs 1D accuracy(5 games) 1D reaction (2 games) 2D motor function(5 games) Each therapy program will be selected and calibrated according to Upper extremity Gross motor/hand functions like Reaching( Forward , upward, Downwards , Sideways), Supination/Pronation , Gripping and Pinching Frequency - 5 times/week for 5 weeks, 30 mins of each intervention Time – 2 mins for each game(total 12 games) with 30 secs of rest in-between(600mins) Progression- Intensity will be increased by increasing level of the game (1-10) if patient achieves 80% score 3 times successively. Note:- In case of difficulty to initiate/complete the game, minimal required assistance will be provided by the therapist.
Comparator Agent	N/A	N/A

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. At least 18 years of age(either male or female) 2. Either traumatic or non-traumatic SCI 3. Less than 12 months from the injury 4. Spinal cord Injury AIS grade A-D, NLI: C4-C8 5. Able to tolerate sitting position on a wheelchair for at least 30 mins. 6. Able to read and understand either the English or Hindi language.

ExclusionCriteria

Details

1. Moderate to severe spasticity at shoulder, elbow, wrist joints (MAS 2- 4)
2. Having psychiatric or other neurological disorders other than SCI
3. Have extensive fixed contractures in the upper limb of the target hand preventing use of the instrument
4. Head injuries causing cognitive or visual impairment
5. Unstable episodes of Autonomic Dysreflexia.
6. Had uncorrected vision, had pain in the affected upper limb restricting upper limb movement
7. Patients having pressure sores

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Upper extremity motor function 1. Graded Redefined Assessment of Strength Sensibility and Prehension GRASSP-II 2. Capabilities of Upper Extremity Questionnaire CUE-Q 3. International Standards for Neurological Classification of Spinal Cord Injury ISNCSCI(UEMS)	At baseline (T0) and post intervention at 5 weeks

Secondary Outcome

Outcome	TimePoints
Functional Independence- Spinal Cord Independence Measure SCIM-III Quality of Life-International spinal cord society (ISCoS) QOL basic dataset V 1.0 User evaluation and satisfaction-Quebec User Evaluation of Satisfaction with assistive Technology (QUEST-2.0)	At baseline (T0)and Post intervention at 5 weeks (T1)

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
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)

10/06/2025

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="8"
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 pilot clinical trial will investigate the feasibility and effectiveness of a gamified sensor-based rehabilitation protocol for improving upper extremity motor function in individuals with cervical spinal cord injury . It will be conducted at Sri Balaji Action Medical Institute, New Delhi, India. The study utilizes the PABLO system of Tyromotion company integrating motion sensors and interactive games to promote task specific training over a 5-week intervention period. Participants will be engaging in structured game based therapy designed to enhance upper limb functions using real-time feedback.The study adopts a one-group pretest-posttest design with 20 participants with ASIA AIS categories A to D with neurological level of injury from C4 to C8. Following outcome measures will be used to assess various outcomes such as GRASSP-II, SCIM-III, UEMS, CUE-Q, and ISCoS QOL dataset. Preliminary findings will assess user acceptability, clinical relevance, and functional improvement, laying the foundation for future controlled trials in neurorehabilitation.