NCT01328301

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 31, 2011

Last Update Submit

March 18, 2015

Conditions

Keywords

gaithemiplegiatreadmillphysiotherapyrehabilitation

Outcome Measures

Primary Outcomes (3)

  • change in Walking speed

    Change in walking speed from baseline to post-treatment, an expected average of 2 weeks

  • change in stride length

    Change in stride length from baseline to post-treatment, an expected average of 2 weeks

  • change in cadence

    Change in cadence from baseline to post-treatment, an expected average of 2 weeks

Secondary Outcomes (1)

  • change in Berg's balance score

    Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks

Study Arms (2)

Speed-dependent treadmill training (SDT)

EXPERIMENTAL

Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed

Other: Experimental

speed-stable treadmill training

ACTIVE COMPARATOR

Control subjects received gait training on the treadmill with a steady speed.

Other: Speed-stable treadmill training

Interventions

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.

Also known as: Treadmill training with increasing speed
Speed-dependent treadmill training (SDT)

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.

Also known as: Treadmill training with steady speed
speed-stable treadmill training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margaret Mak

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret KY Mak, PhD

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations