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Power Training Post-stroke

Skeletal Muscle Plasticity As An Indicator of Functional Performance Post-Stroke

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01970592
Enrollment
56
Registered
2013-10-28
Start date
2013-10-01
Completion date
2019-05-31
Last updated
2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

exercise, rehabilitation, walking

Brief summary

Hemiparesis, strictly defined as (muscular) weakness affecting one side of the body, is seen in three-quarters of individuals following stroke. Weakness in this population results from both neural and muscular factors which include, respectively, the ability to activate skeletal muscle as well as the force generating capacity of the muscle. The overall goal is to improve walking in persons post-stroke by training subjects with an intervention that specifically targets existing neural and muscular impairments, thereby facilitating locomotor recovery.

Detailed description

A primary impairment associated with post-stroke hemiparesis is the failure to make rapid graded adjustment of muscle force (i.e. muscle power) within the context of purposeful complex synergies (e.g., coordination during walking). Not surprisingly, the impact of stroke on walking is significant, with less than 50% of survivors progressing to independent community ambulation. Even among those who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with \ 75% of persons post-stroke reporting limitations in mobility related to walking. Muscle weakness is the most prominent motor consequence among the nearly 6 million survivors of stroke living in the United States and the strongest predictor of functional disability in this large clinical cohort. To date, the physiological mechanisms that contribute to muscle dysfunction in hemiparetic subjects are largely unstudied. Moreover, evidence regarding the efficacy of interventions aimed at attenuating impaired muscle function and the ensuing functional consequences in the post-stroke population is equivocal and viable therapeutic options to remediate hemiparetic muscle weakness remain among the most pressing challenges for biomedical research. The investigators propose that impaired muscle power (the product of muscle strength and velocity) generation is causal of functional (walking) disability post-stroke. In addition, coordination deficits are also critical determinants of functional performance. The investigators have developed a comprehensive theoretical framework that defines and measures the factors underlying disordered muscle function and coordination and will apply this framework to Post-stroke Optimization of Walking using Explosive Resistance (POWER) training. The investigators' goals over the four year funding period are to 1) quantify neural and muscular adaptations that contribute to impaired muscle power generation post-stroke; 2) assess effects of POWER training on neural and muscular adaptations in paretic and non-paretic muscle; and 3) determine the relationship between changes in neural and muscular adaptations following POWER training and locomotor improvements. Innovative aspects of the proposed work include the novel training intervention; the advanced magnetic resonance assessments; as well as the unique measure of the coordination that the investigators propose. It is the investigators' belief that: a) neural and muscular adaptations following stroke are associated with impaired muscle power generation as well as locomotor ability, b) POWER training attenuates functional deficits by addressing the underlying neural and muscular elements and c) functional improvements following training are predicated on improving the most prominent neural and muscular contributors to muscle power generation. If correct, the data generated will provide an entirely new level of evidence regarding the effectiveness of this novel intervention strategy on improving functional performance as well as the importance of peripheral muscle properties as predictors of locomotor ability post-stroke.

Interventions

BEHAVIORALPOWER 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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* age 50-70, * stroke within the past 6 to 24 months, * residual paresis in the lower extremity (Fugl-Meyer Lower Extremity motor score \<34), * ability to walk without assistance and without an ankle foot orthotic (AFO) on the treadmill 30 seconds at speeds ranging from 0.3 - 0.8 m/s, and * provision of informed consent. * In addition, all subjects who meet criteria for the training portion must complete an exercise tolerance test and be cleared for participation by the study cardiologist.

Exclusion criteria

* Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking; * rating on Modified Ashworth Scale 3 at the knee or ankle; * limited lower extremity range of motion of the knee (passive flexion Range of Motion \[ROM\] \< 90); hip (inability to achieve neutral 0 hip extension); or ankle (inability to achieve 0 of active dorsiflexion); * history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living (ADLs); * History of chronic obstructive pulmonary disease (COPD) or oxygen dependence; * Preexisting neurological disorders, dementia or previous stroke; * History of major head trauma; * Legal blindness or severe visual impairment; * history of significant psychiatric illness * Life expectancy \<1 yr., * Severe arthritis or other problems that limit passive ROM; * post-stroke depression (PHQ-9 10), * History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months; * Uncontrolled diabetes with recent diabetic coma, or frequent insulin reactions; * Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest; * Previous or current enrollment in a trial to enhance motor recovery; * Presence of non-magnetic resonance (MR) compatible implants, pregnancy or severe claustrophobia.

Design outcomes

Primary

MeasureTime frameDescription
Gait Speed8 weeksThe speed the subject chooses to walk when instructed to walk at their comfortable speed

Secondary

MeasureTime frameDescription
Muscle Strength8 weeksThe 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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
50
Total50

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyPhysician Decision1
Overall StudyWithdrawal by Subject4

Baseline characteristics

CharacteristicPOWER
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
6 Participants
Age, Categorical
Between 18 and 65 years
44 Participants
Age, Continuous53.3 years
STANDARD_DEVIATION 16.9
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Maximum voluntary contraction62 foot pounds
STANDARD_DEVIATION 31
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
27 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
23 Participants
Region of Enrollment
United States
50 Participants
Self-selected walking speed0.51 meters per second
STANDARD_DEVIATION 0.29
Sex: Female, Male
Female
28 Participants
Sex: Female, Male
Male
22 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 56
other
Total, other adverse events
3 / 56
serious
Total, serious adverse events
1 / 56

Outcome results

Primary

Gait Speed

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

Time frame: 8 weeks

Population: Individuals completing POWER training

ArmMeasureValue (MEAN)Dispersion
POWERGait Speed0.51 meters per secondStandard Deviation 0.29
Secondary

Muscle Strength

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.

Time frame: 8 weeks

Population: Individuals completing POWER training

ArmMeasureValue (MEAN)Dispersion
POWERMuscle Strength62 foot poundsStandard Deviation 31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026