Thera-band Resisted Treadmill Training for Chronic Stroke Patients

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974840
• Other study ID #: A-ER-110-027
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2022
• Source: National Cheng Kung University
• Contact: Sang-I Lin
• Phone: 886-6-2757575
• Email: lin31[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• Treadmill training combined with/ without thera-band
Treadmill walking training with thera-band Treadmill walking training without thera-band

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Sang-I Lin

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Walking oxygen uptake	A Ultima Cordi 02 machine will be used to measure VO2 during 5-minute bouts of treadmill walking.	8 weeks
Primary	Balance	Berg Balance scale Minimum scale = 0 Maximum scale = 56 Higher scores indicate better functional balance.	8 weeks