Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 10339 for:    strength

Strength Training to Improve Gait in People With Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03175133
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Strength exercise Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strength training
Strength exercises for ankle PF, hip abduction, and trunk muscles. Exercises will be done in three standard positions of supine, sidelying, prone, seated, and standing. Exercises during the initial 4 weeks will be completed 2x week with supervision of a physical therapist and 2x week at home, for a total of 4x week. For the final 4 weeks of the intervention will be completed 1x week with supervision and 3x week at home.
Other: Strength exercise
Strengthening exercises performed with physical therapist.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175133


Locations
Layout table for location information
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Margaret Schenkman, PT, PhD University of Colorado, Denver

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03175133     History of Changes
Other Study ID Numbers: 16-2610
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
rehabilitation
physical therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases