Multiple Sclerosis
Conditions
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).
Detailed description
This pilot study is designed to test the efficacy and safety of vibration at correcting the typical gait deficits that involve strength and coordination of multiple joints (hip, knee and ankle) in pre- and early swing phases of the gait cycle. Aim 1: Develop a real-time control algorithm, timed by sensor detected gait events, to provide vibration emulating electromyographic (EMG) activity of target muscles during normal gait and verify its functionality in an able-body volunteer. Further, recruit 12 subjects (6 for CV and 6 controls) with gait deficits at the hip, knee and ankle from MS. Impose vibration during the gait cycle so that it emulates muscle activity pattern of normal gait. Perform baseline quantitative gait analyses to determine the spatio-temporal parameters, foot-to-floor clearance, kinematics, kinetics and patterns of EMG activity during walking with and without vibration in treatment group and without vibration in control group. Aim 2: Implement 12 sessions (3/week for a month) of gait training with cyclic vibration emulating normal muscle activity of lower extremities in treatment group and gait training without vibration in control group and repeat baseline gait assessment to test the following hypotheses. Hypothesis 1. Vibration of hip, knee and ankle muscles improves walking speed and foot-to-floor clearance through increased hip and knee pre-swing flexion and improved hip-knee coordination. Hypothesis 2. Gait training with cyclic muscle vibration induces carryover effects that maintain improved walking after vibration is discontinued. Hypothesis 3. Muscle vibration produces no untoward sensations or adverse physiological responses.
Interventions
DEVICEmuscle vibration during walking
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Patients with more than two relapses within the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10MWT | 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. | speed (m/s) |
| Kinematics | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged | Peak hip, knee and ankle flexion during swing |
| Toe Clearance | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged | Toe clearance between foot and the ground during swing |
| Walking Distance | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged | Volitional walking distance at baseline and after gait training with vibration |
Countries
United States
Participant flow
Recruitment details
3
Pre-assignment details
3
Participants by arm
| Arm | Count |
|---|---|
| Muscle Vibration 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.
muscle vibration during walking: 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 and gait training without muscle vibration during walking in control group and repeat gait assessment after gait training. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Muscle Vibration | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 3 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
10MWT
speed (m/s)
Time frame: 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.
Population: Multiple sclerosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subject A | 10MWT | Follow-up without vibration | 1.295 m/s | Standard Deviation 0.07 |
| Subject A | 10MWT | Baseline | 1.1 m/s | Standard Deviation 0 |
| Subject A | 10MWT | Follow-up with vibration | 1.39 m/s | Standard Deviation 0.05 |
| Subject B | 10MWT | Follow-up without vibration | 1.32 m/s | Standard Deviation 0.009 |
| Subject B | 10MWT | Baseline | 0.75 m/s | Standard Deviation 0.09 |
| Subject B | 10MWT | Follow-up with vibration | 1.38 m/s | Standard Deviation 0.05 |
| Subject C | 10MWT | Baseline | 1.39 m/s | Standard Deviation 0.2 |
| Subject C | 10MWT | Follow-up with vibration | 1.86 m/s | Standard Deviation 0.17 |
| Subject C | 10MWT | Follow-up without vibration | 2.18 m/s | Standard Deviation 0.2 |
Primary
Kinematics
Peak hip, knee and ankle flexion during swing
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Population: Multiple sclerosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subject A | Kinematics | Volitional ankle flexion post-vibration training | 14 degrees | Standard Deviation 2.8 |
| Subject A | Kinematics | Volitional knee flexion pre-training | 49 degrees | Standard Deviation 2.4 |
| Subject A | Kinematics | Volitional ankle dorsiflexion pre-training | 11 degrees | Standard Deviation 2.7 |
| Subject A | Kinematics | Volitional hip flexion pre-training | 24 degrees | Standard Deviation 2.4 |
| Subject A | Kinematics | Volitional knee flexion post-vibration training | 61 degrees | Standard Deviation 3.4 |
| Subject A | Kinematics | Volitional hip flexion post-vibration training | 38 degrees | Standard Deviation 1.9 |
| Subject B | Kinematics | Volitional knee flexion post-vibration training | 44 degrees | Standard Deviation 15.8 |
| Subject B | Kinematics | Volitional ankle dorsiflexion pre-training | 13 degrees | Standard Deviation 4.5 |
| Subject B | Kinematics | Volitional hip flexion post-vibration training | 50 degrees | Standard Deviation 5.8 |
| Subject B | Kinematics | Volitional ankle flexion post-vibration training | 11 degrees | Standard Deviation 3.2 |
| Subject B | Kinematics | Volitional hip flexion pre-training | 57 degrees | Standard Deviation 7.4 |
| Subject B | Kinematics | Volitional knee flexion pre-training | 38 degrees | Standard Deviation 16.3 |
| Subject C | Kinematics | Volitional ankle flexion post-vibration training | 15 degrees | Standard Deviation 5.2 |
| Subject C | Kinematics | Volitional hip flexion pre-training | 27 degrees | Standard Deviation 2.3 |
| Subject C | Kinematics | Volitional hip flexion post-vibration training | 30 degrees | Standard Deviation 2.5 |
| Subject C | Kinematics | Volitional knee flexion pre-training | 72 degrees | Standard Deviation 3.5 |
| Subject C | Kinematics | Volitional knee flexion post-vibration training | 74 degrees | Standard Deviation 2.5 |
| Subject C | Kinematics | Volitional ankle dorsiflexion pre-training | 15 degrees | Standard Deviation 4 |
Primary
Toe Clearance
Toe clearance between foot and the ground during swing
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Population: Multiple sclerosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subject A | Toe Clearance | Left leg volitional pre-training | 19.8 mm | Standard Deviation 4.4 |
| Subject A | Toe Clearance | Right Leg volitional pre-training | 17.6 mm | Standard Deviation 4.4 |
| Subject A | Toe Clearance | Left leg volitional post-vibration training | 30.2 mm | Standard Deviation 5.8 |
| Subject A | Toe Clearance | Right volitional post-vibration training | 25.4 mm | Standard Deviation 7.9 |
| Subject B | Toe Clearance | Right volitional post-vibration training | 9.3 mm | Standard Deviation 3.6 |
| Subject B | Toe Clearance | Left leg volitional pre-training | 30.6 mm | Standard Deviation 7.8 |
| Subject B | Toe Clearance | Left leg volitional post-vibration training | 32 mm | Standard Deviation 5.8 |
| Subject B | Toe Clearance | Right Leg volitional pre-training | 9.1 mm | Standard Deviation 2.5 |
| Subject C | Toe Clearance | Right volitional post-vibration training | 24.7 mm | Standard Deviation 4.7 |
| Subject C | Toe Clearance | Right Leg volitional pre-training | 21.5 mm | Standard Deviation 3.4 |
| Subject C | Toe Clearance | Left leg volitional post-vibration training | 25.5 mm | Standard Deviation 3.6 |
| Subject C | Toe Clearance | Left leg volitional pre-training | 21.3 mm | Standard Deviation 3.5 |
Primary
Walking Distance
Volitional walking distance at baseline and after gait training with vibration
Time frame: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subject A | Walking Distance | Volitional pre-training | 347 meters | Standard Deviation 0 |
| Subject A | Walking Distance | Volitional post-vibration training | 361 meters | Standard Deviation 12 |
| Subject B | Walking Distance | Volitional pre-training | 252 meters | Standard Deviation 0 |
| Subject B | Walking Distance | Volitional post-vibration training | 387 meters | Standard Deviation 11 |
| Subject C | Walking Distance | Volitional pre-training | 338 meters | Standard Deviation 0 |
| Subject C | Walking Distance | Volitional post-vibration training | 406 meters | Standard Deviation 0 |