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

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT01328301

Collaborator

Tung Wah Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Experimental Other: Speed-stable treadmill training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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