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Completed

NCT Number: NCT03175133

Strength Training to Improve Gait in People With Multiple Sclerosis

This study will pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. The investigators think that is because strengthening exercises were not targeted to the correct muscle groups. For this study the investigators propose targeting muscle groups that they have found to be strong contributors to walking in a prior study. This is the first study to target these muscles, so the investigators propose doing a small trial to first evaluate the feasibility of the strength program and the outcomes. The investigators will measure strength and walking measures twice before and once after an 8-week strengthening intervention in a single group of 10 people with MS who are able to walk independently. The results of this study will help inform future, larger trials that could change the way strength training is conducted in people with MS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People with MS,
  • Age 18-65,
  • A confirmed diagnosis of MS, and
  • Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and
  • Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds.

Exclusion criteria

  • Subjects are not ambulatory,
  • Subjects rely on a wheelchair,
  • Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics,
  • Walk the T25FW in less than five seconds,
  • Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS),
  • Have pain or other conditions that limit ambulation or ability to test muscle strength,
  • Cannot give consent,
  • Cannot follow simple directions,
  • Have had an exacerbation in the past month,
  • Have had changes to their drug therapy in the last month,
  • Have other neurologic diagnoses, or
  • Are currently undergoing physical therapy for strength training.

Treatment and study plan

Strength exercise

Other

Strengthening exercises performed with physical therapist.

Primary outcomes

  1. Change in Muscle Strength

    Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

    Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests

  2. Change in Timed 25 Foot Walk (T25FW)

    Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

    Gait speed over a 25 foot distance

Secondary outcomes

  1. Change in 6-Minute Walk Test

    Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

    Gait endurance

  2. Change in Dynamic Gait Index

    Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

    Balance during gait and other functional activities

  3. Change in Multiple Sclerosis Walking Scale-12

    Time frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

    Self-report measure of limitations in walking related activities

  4. Change in Patient Specific Functional Scale

    Time frame: Week 0 (Baseline 1); Week 10 (Follow-Up)

    Self reported measure of self-selected limitations in participation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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