Thera-band Resisted Treadmill Training for Chronic Stroke Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: Treadmill training combined with/ without thera-band

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang-I Lin; Phone Number: 5020 886-6-2757575; Email: lin31@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng Kung University
    • Contact: Sang-I Lin, PhD; Phone Number: 5020 +886-6-235-3535; Email: lin31@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treadmill training combined with 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'.	Behavioral: Treadmill training combined with/ without thera-band; Treadmill walking training with thera-band Treadmill walking training without thera-band
Active Comparator: Treadmill training alone; 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; Treadmill walking training with thera-band Treadmill walking training without thera-band

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sang-I Lin

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: A-ER-110-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No