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CTRI Number  CTRI/2025/08/092647 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Improving Daily Life After Spinal Cord Injury: A Client-Centered Approach 
Scientific Title of Study   Effect of task- oriented client- centered training on functional performance and quality of life in patients with spinal cord injury. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja  
Designation  PG student 
Affiliation  College of physiotherapy , Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak 
Address  College of physiotherapy, room no. 4, E- Block, Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak, Haryana, 124001 india

Rohtak
HARYANA
124001
India 
Phone  9050670832  
Fax    
Email  pm13934@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Megha gakhar 
Designation  Associate Professor 
Affiliation  College of physiotherapy , Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak 
Address  College of physiotherapy, room no. 4, E- Block, Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak, Haryana, 124001 india

Rohtak
HARYANA
124001
India 
Phone  9896232146  
Fax    
Email  meghs80@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Pooja  
Designation  PG student 
Affiliation  College of physiotherapy , Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak 
Address  College of physiotherapy, room no. 4, E- Block, Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak, Haryana, 124001 india

Rohtak
HARYANA
124001
India 
Phone  9050670832  
Fax    
Email  pm13934@gmail.com  
 
Source of Monetary or Material Support  
Pt B.D Sharma University of Health Sciences, PGIMS, Rohtak, Haryana, India, 124001 
 
Primary Sponsor  
Name  Pt. B. D. Sharma University of health Sciences, Rohtak 
Address  College of physiotherapy, room no. 4, E- Block, Pt. B.D Sharma University of Health sciences, PGIMS, Rohtak, Haryana, 124001 india 
Type of Sponsor  Government medical college 
 
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 
Dr Pooja  Pt BD Sharma University of Health Sciences, Rohtak  Paraplegia Unit, Orthopedic Ward, Pt BD Sharma PGIMS, Rohtak
Rohtak
HARYANA 		 9050670832

pm13934@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pt. BD Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S240||Concussion and edema of thoracic spinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Rehabilitation  Range of motion exercises, stretching exercises, isometrics, breathing exercises, circulatory exercises, postural control exercises and positioning Total 1 hour session for 3 days/week for 4 weeks 
Intervention  Task-oriented client-centered training  Week 1 and 2: Phase 1 part practice of task-oriented client-centered training of 2 goals Week 3 whole practice week 4 random practice Total 1 hour session for 3 days/week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  48.00 Year(s)
Gender  Both 
Details  1)Participants had neurological levels of injury TI and below, with American Spinal Injury Association Impairment Scale score C and D.
2)Participants Who are able to verbally communicate and cooperate with study procedures.
3)Participants who are willing to participate. 
 
ExclusionCriteria 
Details  1. Participants who had other neurological disease and cardiovascular involvement.

2. Severe contractures or other orthopedic conditions in upper or lower limb.

3. Patient with aphasia and visual problems.

4. Cognitive impairment/psychological illness (diagnosed). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Spinal Cord Independence Measure Version IV (SCIM IV)
Goal Attainment Scale (GAS) 		 Outcome will be assessed at baseline, after 2 week and after 4 week of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
WHOQOL-BREF (Quality of life)  Outcome will be assessed at baseline, after 2 week & after 4 week of intervention 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   18/08/2025 
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="1"
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

Effect of Task-Oriented Client-Centered Training vs Conventional Rehabilitation on Functional Performance and Quality of Life in Patients with Spinal Cord Injury



Background

Spinal cord injury (SCI) disrupts motor and sensory function, resulting in significant disability. Most cases occur in males aged 20–35, primarily due to trauma. Injuries are classified as complete or incomplete using the AIS (American Spinal Injury Association Impairment Scale). SCI affects not only physical health but also emotional well-being and quality of life.



Rationale

Despite the prevalence of SCI, there’s a lack of robust randomized controlled trials (RCTs) examining the comparative effectiveness of task-oriented client-centered training versus conventional rehabilitation. This study aims to fill that gap by evaluating functional and quality of life outcomes.



Research Question

Does task-oriented client-centered training have a greater effect than conventional rehabilitation on functional performance and quality of life in patients with SCI?


Aim

To evaluate the effect of Task-oriented client-centered training on functional performance and quality of life in SCI patients.


Objectives

1. Assess effect of Task-oriented client-centered training and conventional rehab on functional performance.

2. Compare both interventions on performance and quality of life.

3. Assess and compare impact on quality of life using WHOQOL-BREF.


Hypotheses

Null: No significant differences exist between groups.

Alternative: Task-oriented client-centered training significantly improves outcomes compared to conventional rehab.


Study Design

Type: Randomized Controlled Trial

Period: June 2025 – July 2026

Location: Paraplegia Ward, PGIMS, Rohtak

Participants: 40 patients with SCI level T1 and below, AIS C/D

Groups:

Group A: Conventional Rehabilitation

Group B: Task-Oriented Client-Centered Training


Interventions

Conventional Rehab: ROM exercises, isometrics, stretching, breathing exercises, progressive strengthening over 4 weeks.

Task-oriented client-centered training:

Phase 1: Identify patient-specific goals using Goal Attainment Scale (GAS).

Phase 2: Task analysis and custom training plan.

Phase 3: Weekly structured training (part practice, whole practice, random practice).


Outcome Measures

1. SCIM IV (Functional Independence)


2. GAS (Goal Achievement)


3. WHOQOL-BREF (Quality of Life)


Sample Size

40 total (20 per group), based on power calculation from prior research (Singh et al.).


Data Analysis

Descriptive statistics via SPSS.

ANOVA to compare inter-group outcomes.


Review of Literature Highlights

Spooren et al. (2011): Task-oriented client-centered training improves upper limb skills in tetraplegia.

Chompoonimit et al. (2014, 2016): 8-week Task-oriented client-centered training improved physical function and self-esteem.

Choi et al. (2022): Task-oriented client-centered training benefits upper limb and ADL post-stroke.

Pelletier et al. (2023): SCI-specific exercise improves health but is under-address.
 
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