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

NCT04637737 | Unknown DMC

• 1 other identifier: 4-2014-0383
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (8)

• 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)

Study Arms (2)

Training group

EXPERIMENTAL

Device: anterioposterior Weight Shifting Training with Visual Biofeedback

Control group

OTHER

Behavioral: Conventional therapy

Interventions

anterioposterior Weight Shifting Training with Visual Biofeedback 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.

Training group

Conventional therapy BEHAVIORAL

The control group received the usual gait training.

Control group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• quadriplegia
• past history of stroke
• past history of Musculoskeletal disease or history of Neurological diseases

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Deog Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deog Young Kim

CONTACT

+82-2-2228-3714; KIMDY@yuhs.ac

Study Design

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: October 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)