Trial Outcomes & Findings for Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke (NCT NCT00125619)

NCT ID: NCT00125619

Last Updated: 2017-02-17

Results Overview

Overground walking speed determined as rate of walking over a 10 meter distance.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 4 weeks (s/p 12 sessions of locomotor training)
• Results posted on: 2017-02-17

Participant Flow

Participant milestones

Measure	Arm 2: Robot-assisted Rehabilitation got Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

Baseline characteristics by cohort

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 16.9 • n=5 Participants	55.1 years STANDARD_DEVIATION 13.6 • n=7 Participants	56.8 years STANDARD_DEVIATION 14.4 • n=5 Participants
Gender Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Self-selected Overground Walking speed	0.62 meters per second STANDARD_DEVIATION 0.31 • n=5 Participants	0.62 meters per second STANDARD_DEVIATION 0.28 • n=7 Participants	0.62 meters per second STANDARD_DEVIATION 0.28 • n=5 Participants
Fast Walking Speed	0.87 meters per second STANDARD_DEVIATION 0.55 • n=5 Participants	0.72 meters per second STANDARD_DEVIATION 0.37 • n=7 Participants	0.80 meters per second STANDARD_DEVIATION 0.47 • n=5 Participants
Six Minute Walk Test	267.3 distance walked, meters STANDARD_DEVIATION 187.2 • n=5 Participants	234.3 distance walked, meters STANDARD_DEVIATION 141.2 • n=7 Participants	250.8 distance walked, meters STANDARD_DEVIATION 161.1 • n=5 Participants
Step-length Asymmetry	0.53 ratio STANDARD_DEVIATION 0.58 • n=5 Participants	0.39 ratio STANDARD_DEVIATION 0.37 • n=7 Participants	0.45 ratio STANDARD_DEVIATION 0.48 • n=5 Participants
Lower Extremity Fugl-Meyer Motor Assessment	23.0 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	21.4 units on a scale STANDARD_DEVIATION 5.1 • n=7 Participants	23 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants
Short Physical Performance Battery	6.9 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	7.8 units on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	7.31 units on a scale STANDARD_DEVIATION 3.1 • n=5 Participants
Berg Balance Scale	46.9 units on a scale STANDARD_DEVIATION 7.5 • n=5 Participants	47 units on a scale STANDARD_DEVIATION 7.0 • n=7 Participants	46.9 units on a scale STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks (s/p 12 sessions of locomotor training)

Overground walking speed determined as rate of walking over a 10 meter distance.

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Self-selected Overground Walking Speed	0.72 meters/s Standard Deviation 0.38	0.65 meters/s Standard Deviation 0.29

SECONDARY outcome

Timeframe: 4 weeks (s/p 12 training sessions)

Fastest comfortable walking speed measured while walking overground

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Fast Walking Speed	0.96 meters/s Standard Deviation 0.66	0.70 meters/s Standard Deviation 0.33

SECONDARY outcome

Timeframe: 4 weeks

distance, in meters, walked overground over a six minute interval.

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Six Minute Walk	278.1 meters Standard Deviation 176.5	212.4 meters Standard Deviation 113.5

SECONDARY outcome

Timeframe: 4 weeks

measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Step Length Ratio (Abs)	0.37 ratio Standard Deviation 0.46	0.34 ratio Standard Deviation 0.35

SECONDARY outcome

Timeframe: 4 weeks

Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Lower Extremity Fugl-Meyer Motor Assessment	25.6 units on a scale Standard Deviation 5	22.4 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 4 weeks

Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Short Physical Performance Battery	7.9 units on a scale Standard Deviation 3.2	8.5 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 4 weeks

Clinical measure of balance

Outcome measures

Measure	Arm 2: Robot-assisted n=8 Participants Rehabilitation for Post-stroke Hemiparesis Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support).	Arm 1: Therapist Assisted n=8 Participants Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
Berg Balance Scale	48.3 units on a scale Standard Deviation 6.8	51.0 units on a scale Standard Deviation 5.4

Adverse Events

ARM2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 1

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. Carolynn Patten

VA Brain Rehabilitation Research Center

Phone: 352.376.1611

Email: patten@phhp.ufl.edu

Results disclosure agreements

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