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

CompletedNot a drug-phase studyMS (type not specified)NCT03117881

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • DirectCAM
  • TeleCAM
  • rDirectCAM

Results by group

Change in Pain

48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

GroupValueIntervalNumber analysed
DirectCAM1.64 score on a scale-0.6–3.88382
TeleCAM1.53 score on a scale-0.72–3.78377
rDirectCAM-2.12 score on a scale-7.4–3.1568

DirectCAM

1.64

TeleCAM

1.53

rDirectCAM

-2.12

Change in Fatigue

48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

GroupValueIntervalNumber analysed
DirectCAM-2.57 score on a scale-3.9–-1.24375
TeleCAM-3.58 score on a scale-4.92–-2.23368
rDirectCAM-1.36 score on a scale-4.49–1.7768

DirectCAM

-2.57

TeleCAM

-3.58

rDirectCAM

-1.36

Change in Quality of Life (Physical Component)

48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

GroupValueIntervalNumber analysed
DirectCAM1.34 score on a scale0.36–2.86355
TeleCAM1.86 score on a scale0.91–2.86350
rDirectCAM0.70 score on a scale-1.44–2.8368

DirectCAM

1.34

TeleCAM

1.86

rDirectCAM

0.7

Change in Quality of Life (Mental Component)

48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

GroupValueIntervalNumber analysed
DirectCAM0.42 score on a scale-1.06–1.9355
TeleCAM1.10 score on a scale-0.38–2.57350
rDirectCAM-1.09 score on a scale-4.38–2.1968

DirectCAM

0.42

TeleCAM

1.1

rDirectCAM

-1.09

Change in Physical Activity

48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

GroupValueIntervalNumber analysed
DirectCAM3.74 score on a scale-5.02–12.51319
TeleCAM6.46 score on a scale-2.17–15.09330
rDirectCAM3.13 score on a scale-14.2–20.4768

DirectCAM

3.74

TeleCAM

6.46

rDirectCAM

3.13

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
DirectCAM4250 (0.0%)0
TeleCAM4122 (0.5%)0
rDirectCAM740 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Pain

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    PainQuality of life (reported by participants)
  • Change in Fatigue

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Fatigue
  • Change in Quality of Life (Physical Component)

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Quality of life (reported by participants)
  • Change in Quality of Life (Mental Component)

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Quality of life (reported by participants)
  • Change in Physical Activity

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Physical function

Other measures (6)

  • Change in Balance (Berg Balance Scale)

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Walking and mobility
  • Change in Balance (Five Times Site to Stand)

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Walking and mobility
  • Change in Endurance

    48 weeks for DirectCAM and TeleCAM.

    Walking and mobility
  • Change in Gait (Timed Up and Go)

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Walking and mobility
  • Change in Gait (Timed 25-Foot Walk)

    48 weeks for DirectCAM and TeleCAM.

    Disability progressionWalking and mobility
  • Change in Grip Strength

    48 weeks for DirectCAM and TeleCAM and 12 weeks for rDirectCAM.

    Arm and hand functionPhysical function

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* Physician permission to participate in the study * Mild to moderate disability (i.e., ambulate with/without assistive device, Patient-Determined Disease Steps [PDDS] 0 - 7 * Able to use arms/legs for exercise

Exclusion criteria

* Significant visual acuity that prevents seeing a tablet screen to follow home exercise program * Cardiovascular disease event within the last six months, several pulmonary disease, and/or renal failure * Active pressure ulcers * Currently pregnant * Within 30 days of receiving a rehabilitation program * Already meeting physical activity guidelines (GLTEQ > 24)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.**

Papers

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History

    1. Started

      Jan 2018

    2. Main results due

      Oct 2021

    3. Finished

      Oct 2022

    4. Results posted

      Dec 2024

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