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Tele-Exercise for Spinal Cord Injury

N/A
Recruiting
Led By Margaret Finley, PhD
Research Sponsored by Drexel University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported age between 18-75 years
Report a complete or incomplete SCI of ASIA grade A, B, C, or D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to pre-program
Awards & highlights

Study Summary

This trial will examine the efficacy of an integrated, participant-centered tele-health physical activity program for individuals with SCI on psychological and social factors.

Who is the study for?
This trial is for adults aged 18-75 with spinal cord injury (SCI) who've lived with the injury for at least a year. They must be able to participate in virtual classes, have some shoulder mobility, and not be in structured rehabilitation. Excluded are those with recent fractures or hospitalization, active pressure ulcers, severe vision loss, or other neurological conditions.Check my eligibility
What is being tested?
The study tests an 8-week group tele-exercise program designed to improve physical confidence and strength through virtual classes twice a week. It aims to assess psychological and social benefits using both surveys and interviews before and after the program.See study design
What are the potential side effects?
Since this is an exercise-based intervention rather than medication, typical drug side effects aren't expected. However, participants may experience muscle soreness or fatigue related to increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My spinal cord injury is classified as ASIA A, B, C, or D.
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I am not currently in a structured rehabilitation program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to pre-program
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to pre-program for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form at Week 8
Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 8
Change in exercise self-efficacy on the Exercise Self-Efficacy Scale at Week 8
+11 more
Secondary outcome measures
Accelerometry
Change in depression on the Spinal Cord Injury Quality of Life Measurement System-Depression Short Form from baseline to pre-program (Waitlist control group only)
Change in exercise outcome expectations on the Multidimensional Outcome Expectations for Exercise (MOESS) at Week 16
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist ControlExperimental Treatment1 Intervention
The waitlist control group will complete all quantitative measures as a baseline (baseline-control) and will be instructed to continue their activities as usual, with measures obtained again at 8-weeks (post-control/pre-program). Following the initial 8-week baseline, each waitlist group will participate in pre-intervention semi-structured interview or small focus group with the post-control measures as pre-intervention assessment. They will join the tele-exercise intervention with all measures at 8-weeks (post-intervention) and with leisure time physical activity and quality of life assessed at 16-weeks following initiation of the program.
Group II: Group Tele-exercise ClassExperimental Treatment1 Intervention
Volunteers will be asked to participate in the group online exercise class 2 times per week for 8 weeks. Each activity session will last about 60 minutes and will focus on mind-body practices, tailored to physical and emotional needs of individuals with SCI. Class will be taught by a physical therapist who is an experienced community exercise instructor. Class will be co-led by a person who is living with SCI (one of our community partners). Classes will take place over a secure virtual platform (Zoom). Before beginning and after completion of the program, participants will be asked to participate in small group interviews to share expectations and experiences of the study

Find a Location

Who is running the clinical trial?

The Craig H. Neilsen FoundationOTHER
55 Previous Clinical Trials
2,900 Total Patients Enrolled
Pennsylvania Department of HealthOTHER_GOV
41 Previous Clinical Trials
998,360 Total Patients Enrolled
Drexel UniversityLead Sponsor
150 Previous Clinical Trials
47,730 Total Patients Enrolled

Media Library

Group tele-exercise Clinical Trial Eligibility Overview. Trial Name: NCT05360719 — N/A
Spinal Cord Injury Research Study Groups: Group Tele-exercise Class, Waitlist Control
Spinal Cord Injury Clinical Trial 2023: Group tele-exercise Highlights & Side Effects. Trial Name: NCT05360719 — N/A
Group tele-exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360719 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor accept participants who are younger than 75 years of age?

"This research is inviting individuals aged 18 or older and younger than 75 to participate in the clinical trial."

Answered by AI

What is the projected enrollment for this clinical trial?

"Affirmative. The clinicaltrials.gov database reveals that this trial, originally published on April 30th 2022 and recently updated November 3rd 2022, is currently open for enrollment. 35 participants are needed at a single site of research."

Answered by AI

What aims is the clinical trial attempting to accomplish?

"The main metric evaluated in this clinical trial over the course of a 0 week pre-program and 8 week post-program period is Changes in self-esteem as measured by the Spinal cord injury Quality of Life Measurement System Self Esteem Short Form. Secondary outcomes include Change in Pain Interference, Change in Participation In Social Roles, and Change in Leisure Time Physical Activity Behavior as quantified by the LTPAQ SCI."

Answered by AI

What criteria must a patient fulfill to be eligible for this experiment?

"This investigation is attempting to enrol 35 individuals with spinal cord injuries aged 18-75. To be considered, potential participants must have an ASIA grade A/B/C/D SCI that occurred more than 12 months ago and demonstrate shoulder elevation of 25%, in addition to meeting ACSM standards for physical activity participation and having access to the internet."

Answered by AI

Is it still possible for participants to join this investigation?

"Clinicaltrials.gov states that this clinical trial is actively seeking participants, with a first post date of April 30th 2022 and most recent edit on November 3rd 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Integrated Tele-exercise for Individuals With Spinal Cord Injury
Margaret A. Finley 2022. "Integrated Tele-exercise for Individuals With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05360719.
~0 spots leftby Apr 2024
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