Trial Outcomes & Findings for Power Training Post-stroke (NCT NCT01970592)

NCT ID: NCT01970592

Last Updated: 2020-03-06

Results Overview

The speed the subject chooses to walk when instructed to walk at their "comfortable speed"

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-03-06

Participant Flow

The pool of candidates were recruited from rehabilitation programs at the Medical University of South Carolina; the Ralph H. Johnson VAMC; and Charleston area communities.

After enrollment, participants were thoroughly evaluated for functional and cognitive impairments as well as physical performance. Descriptive physical performance testing included the lower extremity Fugl-Meyer Assessment (FMA-LE), Stroke Impact Scale (SIS), Berg Balance Scale (BBS) and the NIH Stroke Scale.

Participant milestones

Measure	POWER Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking
Overall Study STARTED	56
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	POWER Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Adverse Event	1

Baseline Characteristics

Power Training Post-stroke

Baseline characteristics by cohort

Measure	POWER n=50 Participants Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	53.3 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants
Self-selected walking speed	0.51 meters per second STANDARD_DEVIATION 0.29 • n=5 Participants
Maximum voluntary contraction	62 foot pounds STANDARD_DEVIATION 31 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Individuals completing POWER training

The speed the subject chooses to walk when instructed to walk at their "comfortable speed"

Outcome measures

Measure

POWER n=50 Participants Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking

Gait Speed

0.51 meters per second Standard Deviation 0.29

SECONDARY outcome

Timeframe: 8 weeks

Population: Individuals completing POWER training

The strength of the paretic lower leg muscles will be measured by asking the participants to contract their muscles as forcefully as possible. Testing will be conducted on a specialized machine called an isokinetic dynamometer. This testing is designed to assess the ability to generate muscle power. Before testing the participants will be asked to perform 5 minutes of low intensity cycling. Strength testing will include movements at the hip, knee and ankle in both legs.

Outcome measures

Measure

POWER n=50 Participants Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking

Muscle Strength

62 foot pounds Standard Deviation 31

Adverse Events

POWER

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure

POWER n=56 participants at risk Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking

Respiratory, thoracic and mediastinal disorders Medical DIagnosis

1.8% 1/56 • Number of events 1 • 5 years

Other adverse events

Measure

POWER n=56 participants at risk Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking

Musculoskeletal and connective tissue disorders Participant Fall

5.4% 3/56 • Number of events 56 • 5 years

Additional Information

Chris Gregory

Medical University of South Carolina

Phone: 8437921078

Email: gregoryc@musc.edu

Results disclosure agreements

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