Error-augmented Walking on Gait Performance and Brain Activities in Stroke

Not Applicable

• Conditions: Healthy; Stroke
• Interventions: Other: NO INTERVENTION; Other: Error-augmented treadmill training; Other: Error-augmented concept combined physical therapy group; Other: conventional physical therapy group; Other: active control group

• Registration Number: NCT04455334
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This three-year study is proposed to document the effect and further implementation of error-augmented walking on gait performance and brain activities in individuals with stroke. Note that brain activations of post-stroke individuals during locomotion is a relatively unexplored realm. In the first year, study aims to observe the gait performance and brain activity of post-stroke and healthy participants when they walk on the split-belt treadmill, which inputs errors and causing adaptation during locomotion. Second year, study focuses on the long-term effect in aspect of brain activation and gait performance after training the post-stroke individuals with error-augmented treadmill walking. Lastly, study aim to investigate the long-term effect of practically applying the concept of error-augmented training strategy into clinical physical therapy.

The first-year study is a cross-sectional study to recruit post-stroke and healthy participants. Gait performance will be measured by GaitUp system and brain activity during each walking trails will be measured concurrently by functional near infrared spectroscopy (fNIRS). Cadence, stride time, stride length and swing cycle are the gait parameters that will be recorded. Also, symmetry ratio and variability of temporal and spatial parameters will also be calculated. Brain area of interest in this study will be bilateral premotor cortex (PMC), supplementary motor area (SMA) and medial part of primary motor cortex (M1). Study will run one-way analysis of variance (ANOVA) with repeated measures and, if needed, Tukey post hoc test will be used to document the within group and between group differences with p\<.05.

The second year and third year study are single-blinded (assessor), randomized controlled trials. In the second year, study will recruit and randomize post-stroke participants into one of the two training groups, error-augmented treadmill training group (ETT group) and active control group (AC group). In ETT group, participants will practice split-belt treadmill walking. And participants in AC group will received traditional treadmill walking. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. There will be three evaluations, chronologically, on one day before intervention, one day after completion of intervention and one month after completion of intervention. Gait performance, brain activity, dynamic gait index and sensorimotor ability of lower extremity will be documented. Two-way ANOVA and Tukey post-hoc test will be used to determine the training and follow-up effects with p\< .05. During the third year, individuals with stroke will be recruited and randomized to one of the two group, error-augmented concept combined physical therapy group (EAPT group) and conventional physical therapy group (CPT group). Participants in the CPT group will receive thirty-minute conventional physical therapy each session. Instead of training on a split-belt treadmill, participants in EAPT group will receive fifteen-minute walking trainings that implement the error-augmented concept and another fifteen-minute conventional physical therapy each session. The training duration will be 40 minutes per session, 3 sessions per week for a total of 4 weeks for every group. The outcome measurements, and statistical analysis are the same as those described in the second year.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-07-02
• Study Start: 2020-07-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-21
• Primary Completion: 2023-06-03
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy	NO INTERVENTION	year 1 study
Error-augmented treadmill training	Error-augmented treadmill training	year 2 study
Error-augmented concept combined physical therapy group	Error-augmented concept combined physical therapy group	year 3 study
conventional physical therapy group	conventional physical therapy group	year 3 study
stroke	NO INTERVENTION	year 1 study
active control group	active control group	year 2 study

Primary Outcome Measures

Name	Time	Method
Change of walking performance - stride time	Change from Baseline cadence at 8 weeks	The unit is seconds
Change of walking performance - swing cycle	Change from Baseline cadence at 8 weeks	The unit is percentage (%)
Change of walking performance - Cadence	Change from Baseline cadence at 8 weeks	The unit is steps per minutes
Change of walking performance - stride length	Change from Baseline cadence at 8 weeks	The unit is cm
Change of walking performance - symmetry ratio	Change from Baseline cadence at 8 weeks	V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Change of walking performance - variability	Change from Baseline cadence at 8 weeks	CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)

Secondary Outcome Measures

Name	Time	Method
Brain activities over primary motor cortex	Change from Baseline cadence at 8 weeks	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over supplementary motor area	Change from Baseline cadence at 8 weeks	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.
Brain activities over premotor cortex	Change from Baseline cadence at 8 weeks	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan