CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 911 enrolled
Drug / intervention
DirectCAM +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03117881
NCT03117881N/ACompleted

Comparative Effectiveness Trial Between a Clinic- and Home-Based Complementary and Alternative Medicine Telerehabilitation Intervention for Adults With Multiple Sclerosis (MS)

University of Alabama at Birmingham·interventional·Posted Apr 18, 2017·Updated Dec 11, 2024

In Brief

A clinical study evaluating DirectCAM, TeleCAM, and 1 other intervention for Multiple Sclerosis. Completed, enrolled 911 participants across 40 sites.

Detailed Summary

The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups. \*\*On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.\*\*

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 18, 2017
Enrollment StartJan 8, 2018
Primary CompletionOct 30, 2021
Study CompletionOct 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.2 years ago

Interventions

DirectCAMbehavioral

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.

TeleCAMbehavioral

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.

rDirectCAMbehavioral

The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.