| CTRI Number |
CTRI/2026/01/101137 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Aerobic Exercise for upper limbs with Arm Ergometer and by using Arm Crank Exercise for Spinal Cord Injured Tetraplegic Patients |
|
Scientific Title of Study
|
Effectiveness of Upper Extremity Aerobic Exercise with Arm Ergometer and Arm Crank Exercise |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Emran Hossain |
| Designation |
Lecturer |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Department of Physiotherapy, BHPI, CRP, Savar, Dhaka, Bangladesh.
C-64/1, Majidpur, Savar, Dhaka.
Not Applicable
N/A
1340
Other |
| Phone |
8801515202923 |
| Fax |
|
| Email |
physio.emran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Mohammad Anwar Hossain |
| Designation |
Senior Consultant and Head of Physiotherapy Department |
| Affiliation |
Centre for the Rehabilitation of the Paralysed (CRP) |
| Address |
Department of Physiotherapy, CRP, Savar, Dhaka, Bangladesh.
C-64/1, Majidpur, Savar, Dhaka.
Not Applicable
N/A
1340
Other |
| Phone |
8801753559932 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Fabiha Alam |
| Designation |
Assistant Professor |
| Affiliation |
Bangladesh Health Professions Institute (BHPI) |
| Address |
Department of Physiotherapy, BHPI, CRP Road, CRP, Savar, Dhaka, Bangladesh.
Not Applicable
N/A
1340
Other |
| Phone |
8801723547278 |
| Fax |
|
| Email |
dishaphysio@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Centre for the Rehabilitation of the Paralysed (CRP) |
|
|
Primary Sponsor
|
| Name |
Md Emran Hossain |
| Address |
Bangladesh Health Professions Institute (BHPI),
Centre for the Rehabilitation of the Paralysed(CRP) |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Md Emran Hossain |
Centre for the Rehabilitation of Paralysed (CRP) |
Department of physiotherapy, Savar, Dhaka, Bangladesh.
|
01515202923
physio.emran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHPI Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercise with ergometer and arm crank exercise |
Intervention Description (Experimental Group):
Participants in the experimental group received aerobic exercise training using an arm ergometer and arm crank, designed specifically for individuals with tetraplegia. The training included:
Frequency: 2 sessions per week
Duration per session: 1. 15 to 20 minutes in the first 2 weeks
2. 20 to 30 minutes in the third and fourth weeks
3. 30 to 40 minutes from the fifth week to the end of the training program.
Total duration: 8 weeks
Progression: Gradual increases in resistance and speed as tolerated
Supervision: All sessions were conducted under physiotherapist supervision to ensure safety and correct technique.
Control Group (Conventional Group):
Participants in the control group received standard physiotherapy care, which included:
Passive and active range of motion exercises
Strengthening exercises
Positioning and functional task training
Breathing exercises and postural re-education
Duration and frequency matched to the experimental group |
| Comparator Agent |
Usual |
usual care protocol will depend
on physiotherapist. Repetition and duration of treatment will
set by individual therapist. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with SCI resulting in incomplete or complete tetraplegia admitted in CRP
2. At least one month post injury
3. Age between 16 to 65 years
4. Patients who obtained medical clearance and discharged
5. Patients with intact cognition included in this study could correctly follow the instructions of the physiotherapist for the interventions.
6. Those who were motivated and given consent to be included in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with secondary health complications
2.Those who are not motivated and do not want to give consent excluded from studying.
3. Patients who did not complete the rehabilitation phase
4.Medically and mentally unstable patients were excluded from this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in upper limb muscle strength (shoulder, elbow, wrist) assessed via manual muscle testing and dynamometry. |
At baseline and After 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life assessed using WHOQoL-BREF across physical, psychological, social, and environmental domains.
Reduction in depression and anxiety levels measured via Hospital Anxiety and Depression Scale (HADS).
Increase in motor scores at discharge, evaluated through neurological assessments.
Monitoring of changes in respiratory rate as a supporting physiological measure. |
Baseline (Pre-test):
Before the intervention begins (Week 0)
Post-intervention (Follow-up):
After completion of the 8-week intervention program (Week 8) |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="0"
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)
|
28/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="10" |
|
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 randomized controlled trial was conducted to assess the effectiveness of upper extremity aerobic exercise using an arm ergometer and arm crank in individuals with tetraplegia. The study was carried out at the Centre for the Rehabilitation of the Paralysed (CRP), Savar, Bangladesh. A total of 30 participants were randomized into an experimental group (aerobic exercise and conventional physiotherapy) and a control group (conventional physiotherapy only). The intervention was administered over 8 weeks. Primary outcomes included upper limb ROM, muscle strength, SCIM scores, and VO2 max. Secondary outcomes included WHOQoL-BREF, HADS, and motor scores. Results showed significant improvements in the experimental group in strength, function, and cardiovascular capacity. The findings support the inclusion of upper limb aerobic training in SCI rehabilitation protocols. |