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Clinical Trials/NCT04974840
NCT04974840
Unknown
Not Applicable

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

Sang-I Lin1 site in 1 country80 target enrollmentSeptember 1, 2021
ConditionsChronic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
Sang-I Lin
Enrollment
80
Locations
1
Primary Endpoint
Balance
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
July 31, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sang-I Lin
Responsible Party
Sponsor Investigator
Principal Investigator

Sang-I Lin

Professor

National Cheng Kung University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Balance

Time Frame: 8 weeks

Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.

stride characteristics

Time Frame: 8 weeks

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.

Walking oxygen uptake

Time Frame: 8 weeks

A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.

Study Sites (1)

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