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

NCT ID: NCT04637737

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training group

Group Type EXPERIMENTAL

anterioposterior Weight Shifting Training with Visual Biofeedback

Intervention Type DEVICE

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.

Control group

Group Type OTHER

Conventional therapy

Intervention Type BEHAVIORAL

The control group received the usual gait training.

Interventions

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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.

Intervention Type DEVICE

Conventional therapy

The control group received the usual gait training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deog Young Kim

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Deog Young Kim

Role: CONTACT

Phone: +82-2-2228-3714

Email: [email protected]

Facility Contacts

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Deog Young Kim

Role: primary

Other Identifiers

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4-2014-0383

Identifier Type: -

Identifier Source: org_study_id