Trial Outcomes & Findings for Muscle Vibration in MS to Improve Walking (NCT NCT03403413)

NCT ID: NCT03403413

Last Updated: 2020-05-08

Results Overview

speed (m/s)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 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.
• Results posted on: 2020-05-08

Participant Flow

3

3

Participant milestones

Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

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.

Overall Study Lack of Efficacy

2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Muscle Vibration n=3 Participants 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.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	0 Participants n=3 Participants
Sex: Female, Male Male	3 Participants n=3 Participants
Region of Enrollment United States	3 Participants n=3 Participants

PRIMARY outcome

Timeframe: 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

speed (m/s)

Outcome measures

Measure	Subject A n=1 Participants 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.	Subject B n=1 Participants 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.	Subject C n=1 Participants 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.
10MWT Baseline	1.1 m/s Standard Deviation 0	0.75 m/s Standard Deviation 0.09	1.39 m/s Standard Deviation 0.2
10MWT Follow-up without vibration	1.295 m/s Standard Deviation 0.07	1.32 m/s Standard Deviation 0.009	2.18 m/s Standard Deviation 0.2
10MWT Follow-up with vibration	1.39 m/s Standard Deviation 0.05	1.38 m/s Standard Deviation 0.05	1.86 m/s Standard Deviation 0.17

PRIMARY outcome

Timeframe: 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

Peak hip, knee and ankle flexion during swing

Outcome measures

Measure	Subject A n=1 Participants 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.	Subject B n=1 Participants 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.	Subject C n=1 Participants 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.
Kinematics Volitional hip flexion pre-training	24 degrees Standard Deviation 2.4	57 degrees Standard Deviation 7.4	27 degrees Standard Deviation 2.3
Kinematics Volitional hip flexion post-vibration training	38 degrees Standard Deviation 1.9	50 degrees Standard Deviation 5.8	30 degrees Standard Deviation 2.5
Kinematics Volitional knee flexion pre-training	49 degrees Standard Deviation 2.4	38 degrees Standard Deviation 16.3	72 degrees Standard Deviation 3.5
Kinematics Volitional knee flexion post-vibration training	61 degrees Standard Deviation 3.4	44 degrees Standard Deviation 15.8	74 degrees Standard Deviation 2.5
Kinematics Volitional ankle dorsiflexion pre-training	11 degrees Standard Deviation 2.7	13 degrees Standard Deviation 4.5	15 degrees Standard Deviation 4
Kinematics Volitional ankle flexion post-vibration training	14 degrees Standard Deviation 2.8	11 degrees Standard Deviation 3.2	15 degrees Standard Deviation 5.2

PRIMARY outcome

Timeframe: 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

Toe clearance between foot and the ground during swing

Outcome measures

Measure	Subject A n=1 Participants 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.	Subject B n=1 Participants 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.	Subject C n=1 Participants 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.
Toe Clearance Left leg volitional pre-training	19.8 mm Standard Deviation 4.4	30.6 mm Standard Deviation 7.8	21.3 mm Standard Deviation 3.5
Toe Clearance Right Leg volitional pre-training	17.6 mm Standard Deviation 4.4	9.1 mm Standard Deviation 2.5	21.5 mm Standard Deviation 3.4
Toe Clearance Left leg volitional post-vibration training	30.2 mm Standard Deviation 5.8	32 mm Standard Deviation 5.8	25.5 mm Standard Deviation 3.6
Toe Clearance Right volitional post-vibration training	25.4 mm Standard Deviation 7.9	9.3 mm Standard Deviation 3.6	24.7 mm Standard Deviation 4.7

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Subject A n=1 Participants 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.	Subject B n=1 Participants 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.	Subject C n=1 Participants 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.
Walking Distance Volitional pre-training	347 meters Standard Deviation 0	252 meters Standard Deviation 0	338 meters Standard Deviation 0
Walking Distance Volitional post-vibration training	361 meters Standard Deviation 12	387 meters Standard Deviation 11	406 meters Standard Deviation 0

Adverse Events

Feasibility

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen Selkirk

Loui9s Stokes Cleveland VAMC

Phone: 440-552-0493

Email: stephen.selkirk@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place