Trial Outcomes & Findings for Feasibility and Practice Characteristics of FNS and Gait Robot (NCT NCT00508755)

Results Overview

Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

visit 48, following treatment

Results posted on

2014-04-25

Participant Flow

Subjects were recruited through use of advertisement and by word of mouth to enter this feasibility study.

Participant milestones

Participant milestones
Measure	Gait Training After Stroke Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gait Training After Stroke Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Feasibility and Practice Characteristics of FNS and Gait Robot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gait Training After Stroke n=6 Participants Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: visit 48, following treatment

Population: The sample size for this feasibility study was n=6, constrained by funding limit.

Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.

Outcome measures

Outcome measures
Measure	Gait Robot-alone Training n=6 Participants The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.	FES-Alone n=6 Participants The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.	Combined Gait Robot and FES n=6 Participants The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. allowed for lateral weight shift	0 participants	6 participants	6 participants
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. allowed for knee control-stance phase	6 participants	6 participants	6 participants
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. allowed for ankle movement in sagittal plane	6 participants	6 participants	6 participants

Adverse Events

Gait Training After Stroke

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

Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence

Malcom Randall VA Medical Center, Gainesville Florida

Phone: (352) 376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place