Weight-bearing Training in Stroke Patients.

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: WB Training with external feedback; Other: WB Training without external feedback

• Registration Number: NCT04192240
• Lead Sponsor: Khon Kaen University

Brief Summary

1. Are there differences in weight-bearing (WB) and WB symmetry immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

1. Are there differences in mobility immediately following STS and stepping training with or without using external feedback in ambulatory patients with stroke?

Detailed Description

Subjects are patients with stroke, the age of over 40 years to 74 years, both males and females who are able to walk independently at least 10 meters. Most of them will be recruited from a tertiary rehabilitation center and communities. Subjects have to participate in STS and stepping training with and without using the external feedback for 1 time/condition with a wash-out period for 2 weeks (crossover design). The outcomes will be measured in terms of WB ability during STS and stepping, walking speed, and balance ability.

The primary outcomes were WB ability on the affected limb and WB symmetry. Secondary outcomes were walking speed and balance ability.

Study Timeline

• Study First Submitted: 2019-03-10
• Study Start: 2019-06-01
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Primary Completion: 2020-10-19
• Study Completion: 2020-10-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Independent ambulatory patients with chronic stroke (post-stroke time more than 6 months)
• Age at least 40 years to 74 years
• Body mass index (BMI) between 18.5- 29.9 kg/m^2
• Ability of independent walking over at least 10 meters with or without a walking device
• Ability to rise from a chair with or without using their arms
• Ability to follow a command used in the study

Exclusion Criteria

any conditions that may affect ambulatory ability or ability to participate in the study, such as

• Auditory or visual deficits that are unable to be corrected by a hearing aid, glasses or contact lens
• Musculoskeletal pain with a pain scale more than 5 out of 10 on a visual analog scale (VAS)
• Deformity in the limbs or spine that affect ambulatory ability
• Modified Ashworth Scale (MAS) more 2 score
• Unstable cardiovascular, orthopedics, musculoskeletal, or neurological disease other than stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WB Training with external feedback	WB Training with external feedback	WB during sit-to-stand with external feedback for 10 minute and then, WB during stepping training with external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.
WB Training without external feedback	WB Training without external feedback	WB during sit-to-stand without external feedback for 10 minute and then, WB during stepping training without external feedback for 10 minutes. After training, subjects will walk overground for 10 minutes.

Primary Outcome Measures

Name	Time	Method
Weight-bearing (WB) ability and WB symmetry	Prior to and immediately after complete training program in one session

Secondary Outcome Measures

Name	Time	Method
Dynamic balance control using the Timed up and go test (TUGT)	Prior to and immediately after complete training program in one session
Walking speed using the 10 meter-walk test (10MWT)	Prior to and immediately after complete training program in one session

Trial Locations

Locations (1)

Faculty of Associated Medical Science; 🇹🇭 Nai Muang, KhonKaen, Thailand