Muscle Vibration in MS to Improve Walking

NCT03403413 | Terminated Results

• 2 other identifiers: F2177-PRX002177
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 10MWT

  speed (m/s)

  baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected and averaged.

• Kinematics

  Peak hip, knee and ankle flexion during swing

  baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged

• Toe Clearance

  Toe clearance between foot and the ground during swing

  baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged

• Walking Distance

  Volitional walking distance at baseline and after gait training with vibration

  baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged

Study Arms (1)

Muscle Vibration

EXPERIMENTAL

Test feasibility of muscle vibration of tibialis anterior, rectus femoris, short head of biceps and tensor fasciae latae bilaterally during walking for 1 hour 3 times per week for 12 weeks to improve walking speed through improved coordination of hip, knee and ankle flexion.

Device: muscle vibration during walking

Interventions

muscle vibration during walking DEVICE

Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration.

Muscle Vibration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MS diagnosis reviewed and confirmed by neurologist per the revised McDonald criteria \[ \]
• EDDS\>3
• Age 18-70
• Fixed gait deficiency defined as being present for at least 3 months without improvement
• Hip, knee and ankle muscle weakness or increased extensor tone with difficulty to initiate a step
• Ability to ambulate at least 10ft with contact guard.
• Muscle vibration without untoward sensation.
• Sufficient upper extremity function to use walking aids (walkers, crutches, canes).
• Poor hip-knee-ankle coordination during swing
• Hip, knee and ankle joint range within normal limits.
• Ability to clearly understand written and oral direction in English to provide consent.
• BMI \< 30
• Absence of psychological and cognitive problems or chemical dependency
• No acute orthopedic or medical complications

You may not qualify if:

• Presence of demand pacemakers.
• Edema of the affected limb/s.
• Uncontrolled seizures/epilepsy.
• Severe depression.
• Botulin toxin treatment within 12 months.
• Peripheral neuropathy.
• Respiratory disease.
• Chronic pain.
• Rapidly progressive course suggestive of Marburg variant, Hurst encephalomyelitis or PPMS with three or more system involvement.
• Concurrent treatment with Tysabri.
• Cardiac arrhythmias with associated hemodynamic instability.
• Lower extremity injuries that limit range of motion or function
• Joint problems (hip or leg) that limit range of motion or cause pain with movement
• Women during pregnancy
• Patients with a relapse in the 3 months prior to presentation for study evaluation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Stephen Selkirk
• Organization: Loui9s Stokes Cleveland VAMC

stephen.selkirk@va.gov

440-552-0493

Study Officials

• Stephen M. Selkirk, MD PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 18, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 8, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)