Thera-band Resisted Treadmill Training for Chronic Stroke Patients

Not Applicable

• Conditions: Chronic Stroke
• Interventions: Behavioral: Treadmill training combined with/ without thera-band

• Registration Number: NCT04974840
• Lead Sponsor: Sang-I Lin

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.

Study Timeline

• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-23
• Study Start: 2021-09-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. the diagnosis of first time unilateral stroke more than 6 months before
2. the ability to walk for at least 15 m without person assistance
3. apparent gait deficits upon visual inspection by a trained physical therapist or inability in community ambulation, i.e. walking speed < 0.8 m/s
4. resting blood pressure lower than 150/90 mmHg.

Exclusion Criteria

1. older than 75 years
2. inability to follow the experimental instructions or procedures
3. any pain, inflammation, or other conditions that could affect walking
4. medically unstable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill training combined with thera-band	Treadmill training combined with/ without thera-band	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'.
Treadmill training alone	Treadmill training combined with/ without thera-band	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.

Primary Outcome Measures

Name	Time	Method
stride characteristics	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	8 weeks	A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.
Balance	8 weeks	Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan