NCT04441541

Brief Summary

This study aims to investigate the immediate, accumulated, and maintainable effects of treadmill with biofeedback on gait symmetry in individuals with chronic stroke.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

June 14, 2020

Last Update Submit

June 18, 2020

Conditions

Keywords

Gait trainingBiofeedbackTreadmillGait symmetry

Outcome Measures

Primary Outcomes (1)

  • Spatial and temporal gait symmetry

    Temporal symmetry ratio: 1-(single support time of affected limb/single support time of unaffected limb)

    Change from baseline at the first day, 4 weeks, and 8 weeks

Secondary Outcomes (4)

  • Walking speed

    Change from baseline at the first day, 4 weeks, and 8 weeks

  • 6 Minute Walk Test

    Change from baseline at the first day, 4 weeks, and 8 weeks

  • Timed up and Go test

    Change from baseline at the first day, 4 weeks, and 8 weeks

  • Stroke Impact Scale

    Change from baseline at the first day, 4 weeks, and 8 weeks

Study Arms (4)

Treadmill with auditory feedback group

EXPERIMENTAL
Other: Treadmill with auditory feedback

Treadmill with visual feedback group

EXPERIMENTAL
Other: Treadmill with visual feedback

Treadmill with auditory and visual feedback group

EXPERIMENTAL
Other: Treadmill with auditory and visual feedback

Treadmill training group

ACTIVE COMPARATOR
Other: Treadmill training

Interventions

Participants will receive training 3 times per week for 4 weeks (12 sessions).

Treadmill with auditory feedback group

Participants will receive training 3 times per week for 4 weeks (12 sessions).

Treadmill with visual feedback group

Participants will receive training 3 times per week for 4 weeks (12 sessions).

Treadmill with auditory and visual feedback group

Participants will receive training 3 times per week for 4 weeks (12 sessions).

Treadmill training group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single stroke experience
  • Chronic stroke phase: stroke duration ≥ 6 months
  • Independent gait: Functional Ambulation Category (FAC) ≥ 3

You may not qualify if:

  • Cognitive problem (MMSE \< 24)
  • Visual or audio deficiency that might affect training
  • Severe heart insufficiency or uncontrolled arterial hypertension
  • Orthopedic disorders that affecting their gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Central Study Contacts

Yang Yea-Ru, PhD

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 22, 2020

Study Start

July 1, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 22, 2020

Record last verified: 2020-06