Thera-band Resisted Treadmill Training for Chronic Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine if treadmill training combined with thera-band resistance to body support and forward propulsion would be more effective than treadmill training alone in improving over-ground walking ability and reducing energy cost in chronic stroke patients. This study will also characterize the neuromuscular and kinematic strategies to adapt to resisted treadmill walking in non-impaired adults and stroke patients.

Detailed Description
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This study includes chronic stroke patients who will be randomly assigned to treadmill training combined with thera-band or treadmill training alone group to receive 30 min per session, 2 sessions per week for 8 weeks walking training . Functional balance (Berg Balance Scale), gait characteristics during preferred and maximal speed level walking, and oxygen uptake during 5-minute bouts of treadmill walking will be assessed before and after training and at 2-month follow-up. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will also be conducted for subject characterization.

Official Title
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Effects of Thera-band Resisted Treadmill Training on Walking Ability in Chronic Stroke Patients

Conditions
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Chronic Stroke

Intervention / Treatment
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* Behavioral: Treadmill training combined with/ without thera-band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the diagnosis of first time unilateral stroke more than 6 months before the ability to walk for at least 15 m without person assistance apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s resting blood pressure lower than 150/90 mmHg. Exclusion Criteria: older than 75 years inability to follow the experimental instructions or procedures any pain, inflammation, or other conditions that could affect walking medically unstable.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill training combined with thera-band<br>Participants will receive walking training on treadmill with thera-band at the waist. The direction of the thera-band resistance will be straight backward, backward-toward-right, and backward-toward-left. For each direction, the level of resistance and treadmill speed will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. | Behavioral: Treadmill training combined with/ without thera-band<br>* Treadmill walking training with thera-band Treadmill walking training without thera-band<br>|
| Active Comparator: Treadmill training alone<br>Participants will receive treadmill walking training at a speed that will be adjusted to allow the participants to perceive a 10-minute training to be 'slightly difficult'. For each session, there will be three 10-min treadmill walking bouts. | Behavioral: Treadmill training combined with/ without thera-band<br>* Treadmill walking training with thera-band Treadmill walking training without thera-band<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stride characteristics | Wearable movement sensors will be used to measure walking speed, stride length and time, and gait cycle. Ground reaction forces during walking. A force platform will be used to measure ground reaction forces and center of pressure. | 8 weeks | 
| Walking oxygen uptake | A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking. | 8 weeks | 
| Balance | Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance. | 8 weeks |