Thera-band Resisted Treadmill Training for Chronic Stroke Patients

NCT04974840 | Unknown

• 1 other identifier: A-ER-110-027
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Treadmill training combined with thera-band

EXPERIMENTAL

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 training alone

ACTIVE COMPARATOR

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

Interventions

Treadmill training combined with/ without thera-band BEHAVIORAL

Treadmill walking training with thera-band Treadmill walking training without thera-band

Treadmill training alone; Treadmill training combined with thera-band

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sang-I Lin: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

RECRUITING

Central Study Contacts

Sang-I Lin

CONTACT

886-6-2757575; lin31@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: September 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)