Comparative Effectiveness Study Telerehab Versus Conventional
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/1/2019 |
| Start Date: | July 23, 2018 |
| End Date: | January 31, 2022 |
| Contact: | Louise Palmer, MA |
| Email: | louise.palmer@shepherd.org |
| Phone: | 404-350-7513 |
Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery
This study aims to compare the effectiveness of an exercise program delivered in a
conventional facility-based format versus a telerehabilitation format, which takes place in
the home. Exercise can improve mobility and perhaps decrease the rate and extent of
disability in people with MS. Evidence shows that traditional, facility-based exercise
training may help people with MS consistently participate in exercise or to exercise at a
higher, more intense level. Despite this evidence, lack of access to facility-based exercise
programs may make it difficult for people with MS to engage in exercise.Telerehabilitation
(telerehab) has great potential to overcome challenges associated with facility-based
programs. Telerehab can include videoconferencing, remote monitoring of signs and activity,
and dissemination of specialized and individualized information via electronic mechanisms,
such as smartphones and computers. Both facility-based and telerehab exercise training have
yielded positive results in people with MS, but have not been compared head-to-head. The
current study will fill this gap in the evidence base and compare the outcomes of delivering
the same exercise interventions in a facility or in the home/community using a telerehab
approach. The interventions are designed to be identical in content, with the only difference
being the mode of training delivery.
conventional facility-based format versus a telerehabilitation format, which takes place in
the home. Exercise can improve mobility and perhaps decrease the rate and extent of
disability in people with MS. Evidence shows that traditional, facility-based exercise
training may help people with MS consistently participate in exercise or to exercise at a
higher, more intense level. Despite this evidence, lack of access to facility-based exercise
programs may make it difficult for people with MS to engage in exercise.Telerehabilitation
(telerehab) has great potential to overcome challenges associated with facility-based
programs. Telerehab can include videoconferencing, remote monitoring of signs and activity,
and dissemination of specialized and individualized information via electronic mechanisms,
such as smartphones and computers. Both facility-based and telerehab exercise training have
yielded positive results in people with MS, but have not been compared head-to-head. The
current study will fill this gap in the evidence base and compare the outcomes of delivering
the same exercise interventions in a facility or in the home/community using a telerehab
approach. The interventions are designed to be identical in content, with the only difference
being the mode of training delivery.
Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site
study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise
program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The
research study design is a two-stage randomized choice design aimed at non-inferiority.
Five hundred participants with MS who have ambulatory difficulties will be recruited from
seven sites. First level randomization will assign participants to one of two groups - Choice
or No Choice. The participants in Choice will be able to choose in which program they wish to
participate (telerehab or facility-based). Individuals in the No Choice group, will be
further randomized to either the telerehab or facility-based program. The research protocol
and associated tools will be reviewed and approved by all relevant Research Review Committees
before any research takes place. The study will comply with best practices in human subjects'
research including following HIPAA guidelines and using strict informed consent procedures.
Clinical reported outcome measures and patient reported outcome measures will be administered
at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention.
Patient reported outcomes will also be administered at 2-months after the start of the
intervention.
Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the
co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic
Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver;
University of North Carolina, Chapel Hill; the University of Georgia; and the iConquerMS
outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary
and coordinating site for all study activities under Dr. Backus. University of Alabama at
Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training
programs, and statistical analysis under the direction of Dr. Gary Cutter.
This study will yield important data regarding the comparative impact of exercise programs on
MS outcomes and provide information to people with MS, health providers, payers, exercise
partners, and policy makers about how people with MS who have ambulatory difficulties can
safely and effectively exercise.
study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise
program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The
research study design is a two-stage randomized choice design aimed at non-inferiority.
Five hundred participants with MS who have ambulatory difficulties will be recruited from
seven sites. First level randomization will assign participants to one of two groups - Choice
or No Choice. The participants in Choice will be able to choose in which program they wish to
participate (telerehab or facility-based). Individuals in the No Choice group, will be
further randomized to either the telerehab or facility-based program. The research protocol
and associated tools will be reviewed and approved by all relevant Research Review Committees
before any research takes place. The study will comply with best practices in human subjects'
research including following HIPAA guidelines and using strict informed consent procedures.
Clinical reported outcome measures and patient reported outcome measures will be administered
at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention.
Patient reported outcomes will also be administered at 2-months after the start of the
intervention.
Dr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the
co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic
Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver;
University of North Carolina, Chapel Hill; the University of Georgia; and the iConquerMS
outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary
and coordinating site for all study activities under Dr. Backus. University of Alabama at
Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training
programs, and statistical analysis under the direction of Dr. Gary Cutter.
This study will yield important data regarding the comparative impact of exercise programs on
MS outcomes and provide information to people with MS, health providers, payers, exercise
partners, and policy makers about how people with MS who have ambulatory difficulties can
safely and effectively exercise.
Inclusion Criteria:
- Mild to moderate MS
- Has limitations in walking but can walk 25 feet
- Does not participate in a rigorous exercise program
Exclusion Criteria:
- Relapse in the past 30 days
- Other neurological or musculoskeletal disorders
We found this trial at
7
sites
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