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

The Effects of Error-augmented Walking on Gait Performance and Brain Activities in Individuals With Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Healthy
• Intervention / Treatment: Other: NO INTERVENTION; Other: active control group; Other: Error-augmented treadmill training; Other: Error-augmented concept combined physical therapy group; Other: conventional physical therapy group

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanci Liu, Ph.D; Phone Number: 0233668135; Email: yanciliu@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yanci Liu, PHD; Phone Number: 0233668135; Email: yanciliu@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

The inclusion criteria of stroke participants are

1. first unilateral stroke
2. older than 20 years old
3. medically stable
4. lesion site limited in subcortical area
5. having step length asymmetry (asymmetry ratio ≥ 1.08)
6. ability to walk 10 meters independently without an assistive device.

The inclusion criteria of healthy participants are

1. ability to walk 10 meters independently without an assistive device
2. no any other neurological, psychological, or orthopedic disorders known to interfere the walking performance
3. mini-mental status examination scores > 24 points

The exclusion criteria are

1. Participants who are medical unstable
2. cognitive impaired (mini-mental status examination scores < 24 points)
3. diagnosed with other neurological, psychological, or orthopedic disorders known to interfere the participation to the study
4. with the diagnosis which the contraindication includes exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healthy; year 1 study	Other: NO INTERVENTION; NO INTERVENTION
Other: stroke; year 1 study	Other: NO INTERVENTION; NO INTERVENTION
Active Comparator: active control group; year 2 study	Other: active control group; walk on tie-belt treadmill
Experimental: Error-augmented treadmill training; year 2 study	Other: Error-augmented treadmill training; walk on split-belt treadmill
Experimental: Error-augmented concept combined physical therapy group; year 3 study	Other: Error-augmented concept combined physical therapy group; Error-augmented concept combined physical therapy
Active Comparator: conventional physical therapy group; year 3 study	Other: conventional physical therapy group; conventional physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of walking performance - Cadence	The unit is steps per minutes	Change from Baseline cadence at 4 weeks
Change of walking performance - Cadence	The unit is steps per minutes	Change from Baseline cadence at 8 weeks
Change of walking performance - stride time	The unit is seconds	Change from Baseline cadence at 4 weeks
Change of walking performance - stride time	The unit is seconds	Change from Baseline cadence at 8 weeks
Change of walking performance - stride length	The unit is cm	Change from Baseline cadence at 4 weeks
Change of walking performance - stride length	The unit is cm	Change from Baseline cadence at 8 weeks
Change of walking performance - swing cycle	The unit is percentage (%)	Change from Baseline cadence at 4 weeks
Change of walking performance - swing cycle	The unit is percentage (%)	Change from Baseline cadence at 8 weeks
Change of walking performance - symmetry ratio	V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)	Change from Baseline cadence at 4 weeks
Change of walking performance - symmetry ratio	V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)	Change from Baseline cadence at 8 weeks
Change of walking performance - variability	CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)	Change from Baseline cadence at 4 weeks
Change of walking performance - variability	CV(coefficient of variation) = standard deviation/mean x 100% of the stride length(spatial) or stride time(temporal)	Change from Baseline cadence at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain activities over premotor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Brain activities over premotor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks
Brain activities over supplementary motor area	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Brain activities over supplementary motor area	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks
Brain activities over primary motor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 4 weeks
Brain activities over primary motor cortex	A multichannel wearable fNIRS imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) is used to detect the hemodynamics.	Change from Baseline cadence at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index		Change from Baseline cadence at 4 weeks
Dynamic Gait Index		Change from Baseline cadence at 8 weeks
Fugl-Meyer assessment	Sensorimotor impairment of lower extremity	Change from Baseline cadence at 4 weeks
Fugl-Meyer assessment	Sensorimotor impairment of lower extremity	Change from Baseline cadence at 8 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yanci Liu, Ph.D, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Anticipated): June 3, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 202004042RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No