Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RX002177 | Other Identifier | Louis Stokes VA Medical Center |
Not provided
Not provided
Not provided
Funding ran out
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen M. Selkirk, MD PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
3
3
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 and repeat gait assessment after gait training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 10MWT | speed (m/s) | Multiple sclerosis | Posted | Mean | Standard Deviation | 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. |
|
Data were collected over a period of 6 weeks from baseline to final evaluation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feasibility | 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 and repeat gait assessment after gait training. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Selkirk | Loui9s Stokes Cleveland VAMC | 440-552-0493 | stephen.selkirk@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2018 | Jan 29, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2020 | Jan 29, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Kinematics of hip, knee and ankle flexion and speed and endurance of walking with and without vibration | Count of Participants | Participants |
|
| OG001 | Subject B | 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 and repeat gait assessment after gait training. |
| OG002 | Subject C | 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 and repeat gait assessment after gait training. |
|
|
| Primary | Kinematics | Peak hip, knee and ankle flexion during swing | Multiple sclerosis | Posted | Mean | Standard Deviation | degrees | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged |
|
|
|
| Primary | Toe Clearance | Toe clearance between foot and the ground during swing | Multiple sclerosis | Posted | Mean | Standard Deviation | mm | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged |
|
|
|
| Primary | Walking Distance | Volitional walking distance at baseline and after gait training with vibration | Posted | Mean | Standard Deviation | meters | baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Volitional knee flexion pre-training |
|
| Volitional knee flexion post-vibration training |
|
| Volitional ankle dorsiflexion pre-training |
|
| Volitional ankle flexion post-vibration training |
|
|
| Left leg volitional post-vibration training |
|
| Right volitional post-vibration training |
|
|