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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328301
• Other study ID #: mak0001
• Status: Completed
• Phase: N/A
• First received: March 31, 2011
• Last updated: March 18, 2015
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2015
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Margaret Mak	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Tung Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Walking speed		Change in walking speed from baseline to post-treatment, an expected average of 2 weeks	No
Primary	change in stride length		Change in stride length from baseline to post-treatment, an expected average of 2 weeks	No
Primary	change in cadence		Change in cadence from baseline to post-treatment, an expected average of 2 weeks	No
Secondary	change in Berg's balance score		Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks	Yes