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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04637737

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: anterioposterior Weight Shifting Training with Visual Biofeedback Behavioral: Conventional therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.
Other: Control group	Behavioral: Conventional therapy The control group received the usual gait training.

Arm

Intervention/Treatment

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.

Other: Control group

Behavioral: Conventional therapy

The control group received the usual gait training.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Deog Young Kim, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04637737

Other Study ID Numbers:

4-2014-0383

First Posted:

Nov 20, 2020

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 20, 2020