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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
  Purpose

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.


Condition Intervention
Stroke
Other: Experimental
Other: Speed-stable treadmill training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Treadmill training with steady speed

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01328301

Locations
China
Margaret Mak
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Tung Wah East Hopsital
Investigators
Principal Investigator: Margaret KY Mak, PhD Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Dr. Margaret Mak, Department of Rehabilitation Sciences, The Hong Kogn Polytechnic University
ClinicalTrials.gov Identifier: NCT01328301     History of Changes
Other Study ID Numbers: mak0001
Study First Received: March 31, 2011
Last Updated: April 1, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
gait
hemiplegia
treadmill
physiotherapy
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014