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

NCT ID: NCT01328301

Last Updated: 2015-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Speed-dependent treadmill training (SDT)

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Speed-stable treadmill training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Treadmill training with increasing speed; Treadmill training with steady speed

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tung Wah Hospital

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Margaret Kit Yi Mak

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret KY Mak, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Locations

Margaret Mak

Hong Kong, Hong Kong, China

Countries

China

Other Identifiers

mak0001

Identifier Type: -

Identifier Source: org_study_id