Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke

March 18, 2015 updated by: Margaret Kit Yi Mak, The Hong Kong Polytechnic University

Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke

This study aimed to explore whether speed-dependent treadmill training is more effective at improving walking and balance performance than speed-stable treadmill training in patients with subacute stroke. Twenty-six patients with stroke completed 2 weeks of treadmill training. Results showed that speed-dependent treadmill training is more effective at improving walking speed and step length than speed-stable treadmill training in patients with subacute stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: To compare the effects of speed-dependent treadmill training (SDT) on gait and balance performance in patients with sub-acute stroke. Design: Double-blinded randomized controlled trial. Subjects: Twenty-six patients with sub-acute stroke were randomly assigned to SDT (n=13) and control (n=13) groups. Methods: Subjects in the SDT group underwent short interval of walking trials with stepwise increases in the treadmill speed, following the principles of sprint training. Control subjects received gait training on the treadmill with a steady speed (SST). Gait speed, stride length, cadence, and Berg's balance score (BBS) were recorded and analysed before and after the 10 training sessions. Results: Results of two-way repeated measures ANOVA showed significant group x time interactions for gait speed and stride length (p < 0.05). Within each subject group, there were improvements in all gait parameters and BBS (all p < 0.001) after the training program. In addition, the SDT group showed significantly larger percentage increases in gait speed (by 72.8%) and stride length (by 29.2%) than the control subjects (p < 0.02). Conclusions: SDT in patients with sub-acute stroke resulted in larger gains in gait speed and stride length compared with SST. The positive findings provide evidence for clinical practice of SDT in enhancing gait function after stroke.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Margaret Mak

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • first episode of stroke
  • within 1 month of stroke onset
  • hemiparesis resulting from unilateral ischemic stroke
  • Ashworth score of 0 or 1 indicating no spasticity or slight spasticity over the affected lower limb respectively
  • mini-mental status examination score of ≥ 23
  • the ability to walk on level ground without physical assistance and to walk on a treadmill with a minimum speed of 22.2 cm/s for 30s

Exclusion Criteria:

  • neurological diseases other than stroke,
  • active cardiovascular disease (i.e. American Heart Association class C or above),
  • lower limb fractures
  • total hip replacement
  • active rheumatoid arthritis that affected their gait performance
  • Patients who required assistance to ambulate before the stroke were also excluded

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Speed-dependent treadmill training (SDT)
Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed
Other: Experimental
For SDT training, subjects received short intervals of locomotion training with a treadmill. After walking for 30s, the subjects were given two minutes of rest. If they completed the first walking trial safely and without stumbling, the belt speed was increased by 10% on the next trial. However, if a subject failed to complete the first trial, the belt speed was decreased by 10% on the next trial. The speed of the treadmill was adjusted in each subsequent trial according to the same principle. Subjects usually completed 7-8 walking trials in one session. The belt speed was increased by a maximum of five increments within one training session.
Other Names:
  • Treadmill training with increasing speed
ACTIVE_COMPARATOR: speed-stable treadmill training
Control subjects received gait training on the treadmill with a steady speed.
Other: Speed-stable treadmill training
Subjects in the control group walked on the treadmill with the belt speed adjusted according to their fastest over-ground gait speed. There was no adjustment of the belt speed throughout the 30-minute steady-speed treadmill training session.
Other Names:
  • Treadmill training with steady speed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in Walking speed
Time Frame: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
change in stride length
Time Frame: Change in stride length from baseline to post-treatment, an expected average of 2 weeks
Change in stride length from baseline to post-treatment, an expected average of 2 weeks
change in cadence
Time Frame: Change in cadence from baseline to post-treatment, an expected average of 2 weeks
Change in cadence from baseline to post-treatment, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change in Berg's balance score
Time Frame: Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks
Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

Tung Wah Hospital

Investigators

  • Principal Investigator: Margaret KY Mak, PhD, Department of Rehabilitation Sciences, The Hong Kong Polytechnic 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

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (ESTIMATE)

April 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mak0001

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.

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