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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637737
• Other study ID #: 4-2014-0383
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: +82-2-2228-3714
• Email: KIMDY[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Behavioral:
• Conventional therapy
The control group received the usual gait training.

Locations

Country	Name	City	State
Korea, Republic of	Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	before training(0week)
Primary	Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	during training(2week)
Primary	Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	after training(4week)
Primary	Step Length Asymmetric Ratio	Step Length Asymmetric Ratio = paretic step length/non paretic step length	Follow up(8week)
Primary	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)
Primary	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)
Primary	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)
Primary	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)