NCT04436536

Brief Summary

This study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. It was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1 stroke

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 26, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

June 15, 2020

Last Update Submit

September 3, 2021

Conditions

Keywords

strokegaitdual tasksmotor learning

Outcome Measures

Primary Outcomes (1)

  • stride characteristics

    Wearable movement sensors are used to measure stride characteristics, such step length, gait velocity, under different walking conditions (normal, narrow based, dual task)

    2 weeks

Study Arms (2)

training with random speed changes

EXPERIMENTAL

Walking training on treadmill with random speed changes, that is, random sequence of several different walking speeds

Other: Treadmill walking training with random speed changes

training with blocked speed changes

ACTIVE COMPARATOR

Walking training on treadmill with blocked speed changes, that is a steady progression of faster walking speed.

Other: Treadmill walking training with blocked speed changes

Interventions

Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

training with random speed changes

Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.

training with blocked speed changes

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with first stroke for at least 6 months
  • Able to walk for at least 20 minutes independently without exhaustion
  • Residual gait deficits
  • Resting blood pressure is lower than 150/90 mmHg

You may not qualify if:

  • Unable to follow experimental instructions during the process
  • Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability
  • Unstable health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lin Sang-I, PhD

    National Cheng Kung University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy, National Cheng Kung University

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

February 26, 2020

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations