Restoration of Walking in Multiple Sclerosis Using Treadmill Training.

Status Completed

Clinical Trial Summary

The primary purpose of this study is to collect preliminary and pilot data to begin to determine whether the use of body weight support treadmill therapy (BWSTT) with and without driven-gait-orthotics (DGO), results in improved motor recovery and ambulation MS patients with gait impairment

Clinical Trial Description

Gait impairment is a major cause of ongoing disability in patients with multiple sclerosis (MS). New treadmills that provide body weight support and even robotic assistance to the lower limbs have recently been developed and are now commercially available. These treadmills allow the subject to execute the integrated process of walking in a task-specific manner that is repetitively reinforced in a normal pattern. Data from studies using these body-weight supported treadmills (BWSTT) in spinal cord injury and stroke patients suggest that intensive task-specific gait rehabilitative training may help to restore a normative gait pattern, improve overground walking and enhance quality of life in multiple sclerosis patients with neurological gait impairment. In this study, we propose a series of prospective longitudinal clinical studies to collect pilot data on the use of task-specific BWSTT +/- Lokomat on improving ambulation, motor function and quality of life for MS patients with mild to moderate gait difficulty. Pilot data will also be collected for the effect conventional rehabilitation has on ambulation and motor outcomes as well as how these outcomes change during usual care. Our clinical research goals are to capture the initial pilot data (mean changes and variances in ambulation, motor, fatigue and quality of life outcomes) to facilitate the design of a larger clinical trial to test efficacy if these preliminary data are promising. The planned studies will study the effect of two forms of task specific training (BWSTT alone and BWSTT combined with Lokomat) compared to conventional gait rehabilitative methods and usual care ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00156676
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	September 2004
Completion date	September 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05528666` - Risk Perception in Multiple Sclerosis
Completed	`NCT03608527` - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis	N/A
Recruiting	`NCT05532943` - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis	Phase 1/Phase 2
Completed	`NCT02486640` - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed	`NCT01324232` - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis	Phase 2
Completed	`NCT04546698` - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting	`NCT04380220` - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed	`NCT02835677` - Integrating Caregiver Support Into MS Care	N/A
Completed	`NCT03686826` - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting	`NCT05964829` - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis	N/A
Withdrawn	`NCT06021561` - Orofacial Pain in Multiple Sclerosis
Completed	`NCT03653585` - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting	`NCT04798651` - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis	N/A
Active, not recruiting	`NCT05054140` - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis	Phase 2
Completed	`NCT05447143` - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis	N/A
Recruiting	`NCT06195644` - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients	Phase 1
Completed	`NCT04147052` - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis	N/A
Completed	`NCT03591809` - Combined Exercise Training in Patients With Multiple Sclerosis	N/A
Completed	`NCT03594357` - Cognitive Functions in Patients With Multiple Sclerosis
Completed	`NCT03269175` - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.