NCT07115693

Brief Summary

This study investigated the effects of resistive exercises applied with synchronized telerehabilitation on upper extremity functions in patients with SCI who use wheelchairs. A randomized controlled trial included 21 patients with SCI between the ages of between18 and 60. Participants were divided into two groups: the Study Group (n=11) and the Control Group (n=10). Participants in the study group applied resistive exercise with a synchronized telerehabilitation method, while participants in the control group applied a home exercise program. The upper extremity muscle strength of the participants was evaluated with hand-held dynamometer before and after the treatment, physical performance with a 20-meter push test, and physical activity level with Physical Activity Scale for Disabled Individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 4, 2025

Last Update Submit

August 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in upper extremity muscle strength measured by hand-held dynamometer

    Muscle strength of the shoulder flexors, extensors, abductors, and wrist flexors and extensors will be measured bilaterally using a hand-held dynamometer. The outcome is reported in Newtons (N).

    Baseline and after 6 weeks of intervention

Study Arms (2)

Synchronous Telerehabilitation with Resistance Exercises

EXPERIMENTAL

Participants received live, video-based supervised resistance training 3x/week for 6 weeks.

Behavioral: Telerehabilitation-Based Resistance Exercise Program

Home-Based Exercise Program

ACTIVE COMPARATOR

Participants followed an unsupervised exercise program at home for 6 weeks.

Behavioral: Home Exercise Program

Interventions

Participants received synchronous telerehabilitation sessions three times per week for six weeks. Each session lasted 45 minutes and included supervised resistance exercises for upper extremity muscle groups. Exercise bands were chosen based on baseline strength. Pulse oximeters were used to monitor heart rate and oxygen saturation.

Synchronous Telerehabilitation with Resistance Exercises

Participants were given a home-based, unsupervised exercise program to follow three times per week for six weeks. The exercises were taught at the beginning, and adherence was monitored using a physical activity diary. No tele-supervision was provided.

Home-Based Exercise Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 60 years
  • Diagnosed with spinal cord injury classified as ASIA A, B, or C
  • Cooperative and able to follow verbal instructions
  • Has access to online communication devices
  • Partially or fully dependent on a wheelchair
  • Sufficient upper extremity strength to operate a wheelchair
  • Has not undergone surgery in the past 6 months
  • Willing to participate and provided informed consent

You may not qualify if:

  • Unwilling or unmotivated to participate
  • Presence of a progressive disease
  • Fully bedridden
  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkish Spinal Cord Paralytics Association at Hüsnü Ayık Special Care Center

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

April 15, 2023

Primary Completion

February 15, 2024

Study Completion

April 15, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations