Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation

September 3, 2021 updated by: Sang-I Lin, National Cheng Kung University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. The outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The three tasks are normal walking, narrow based walking and obstacle crossing. The three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). The two attention conditions are none and serial subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: training with random speed changes
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
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.
Active Comparator: training with blocked speed changes
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stride characteristics
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Collaborators

Tainan Hospital, Ministry of Health and Welfare

Investigators

  • Study Chair: Lin Sang-I, PhD, National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-107-101-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Treadmill walking training with random speed changes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe