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

NCT04455334 | Unknown

• 1 other identifier: 202004042RIND
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Stroke

Keywords

error augmentation,gait symmetry,brain activation,split-belt treadmill,walking adaptation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Brain activities over premotor cortex

  Change from Baseline cadence at 4 weeks

• Brain activities over premotor cortex

  Change from Baseline cadence at 8 weeks

• Brain activities over supplementary motor area

  Change from Baseline cadence at 4 weeks

• Brain activities over supplementary motor area

  Change from Baseline cadence at 8 weeks

• Brain activities over primary motor cortex

  Change from Baseline cadence at 4 weeks

Other Outcomes (4)

• Dynamic Gait Index

  Change from Baseline cadence at 4 weeks

• Dynamic Gait Index

  Change from Baseline cadence at 8 weeks

• Fugl-Meyer assessment

  Change from Baseline cadence at 4 weeks

Study Arms (6)

healthy

OTHER

year 1 study

Other: NO INTERVENTION

stroke

OTHER

year 1 study

Other: NO INTERVENTION

active control group

ACTIVE COMPARATOR

year 2 study

Other: active control group

Error-augmented treadmill training

EXPERIMENTAL

year 2 study

Other: Error-augmented treadmill training

Error-augmented concept combined physical therapy group

EXPERIMENTAL

year 3 study

Other: Error-augmented concept combined physical therapy group

conventional physical therapy group

ACTIVE COMPARATOR

year 3 study

Other: conventional physical therapy group

Interventions

Error-augmented treadmill training OTHER

walk on split-belt treadmill

Error-augmented treadmill training

active control group OTHER

walk on tie-belt treadmill

active control group

Error-augmented concept combined physical therapy group OTHER

Error-augmented concept combined physical therapy

Error-augmented concept combined physical therapy group

conventional physical therapy group OTHER

conventional physical therapy

conventional physical therapy group

NO INTERVENTION OTHER

NO INTERVENTION

healthy; stroke

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first unilateral stroke
• older than 20 years old
• medically stable
• lesion site limited in subcortical area
• having step length asymmetry (asymmetry ratio ≥ 1.08)
• ability to walk 10 meters independently without an assistive device.
• ability to walk 10 meters independently without an assistive device
• no any other neurological, psychological, or orthopedic disorders known to interfere the walking performance
• mini-mental status examination scores \> 24 points

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yanci Liu, Ph.D

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanci Liu, Ph.D

CONTACT

0233668135; yanciliu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 2, 2020
• Study Start: July 13, 2020
• Primary Completion: June 3, 2023
• Study Completion: July 31, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

TW (1)