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

This study has been completed.
Sponsor:
Collaborator:
Tung Wah East Hopsital
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01328301
First received: March 31, 2011
Last updated: April 1, 2011
Last verified: December 2009

March 31, 2011
April 1, 2011
December 2008
December 2009   (final data collection date for primary outcome measure)
  • change in Walking speed [ Time Frame: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • change in stride length [ Time Frame: Change in stride length from baseline to post-treatment, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • change in cadence [ Time Frame: Change in cadence from baseline to post-treatment, an expected average of 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01328301 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Stroke
  • 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 Name: Treadmill training with increasing 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 Name: Treadmill training with steady speed
  • Experimental: Speed-dependent treadmill training (SDT)
    Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed
    Intervention: Other: Experimental
  • Active Comparator: speed-stable treadmill training
    Control subjects received gait training on the treadmill with a steady speed.
    Intervention: Other: Speed-stable treadmill training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01328301
mak0001
Yes
Dr. Margaret Mak, Department of Rehabilitation Sciences, The Hong Kogn Polytechnic University
The Hong Kong Polytechnic University
Tung Wah East Hopsital
Principal Investigator: Margaret KY Mak, PhD Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
The Hong Kong Polytechnic University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP