Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke

Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.

40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: anterioposterior Weight Shifting Training with Visual Biofeedback; Behavioral: Conventional therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
    • Contact: Deog Young Kim; Phone Number: +82-2-2228-3714; Email: KIMDY@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. less than 6 months after onset of the stroke
2. can stand and walk independently 10m
3. K-MMSE score of at least 15
4. have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
5. over 20 years of age.

Exclusion Criteria:

1. quadriplegia
2. past history of stroke
3. past history of Musculoskeletal disease or history of Neurological diseases

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
Other: Control group	Behavioral: Conventional therapy; The control group received the usual gait training.
Experimental: Training group	Device: anterioposterior Weight Shifting Training with Visual Biofeedback; The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK). Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side. On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value. It is designed to induce the maximum weight shift through the archery game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	before training(0week)
Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	during training(2week)
Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	after training(4week)
Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	Follow up(8week)
Step Length Asymmetric Index	Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]	before training(0week)
Step Length Asymmetric Index	Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]	during training(2week)
Step Length Asymmetric Index	Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]	after training(4week)
Step Length Asymmetric Index	Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic step length +non paretic step length]	Follow up(8week)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

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: 4-2014-0383

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