Clinical trial NCT04637737: Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Official title: Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Step Length Asymmetric Ratio
timeFrame: before training(0week)
measure: Step Length Asymmetric Ratio
timeFrame: during training(2week)
measure: Step Length Asymmetric Ratio
timeFrame: after training(4week)
measure: Step Length Asymmetric Ratio
timeFrame: Follow up(8week)
measure: Step Length Asymmetric Index
timeFrame: before training(0week)
measure: Step Length Asymmetric Index
timeFrame: during training(2week)
measure: Step Length Asymmetric Index
timeFrame: after training(4week)
measure: Step Length Asymmetric Index
timeFrame: Follow up(8week)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Deog Young Kim
role: PRINCIPAL_INVESTIGATOR
References: