Clinical trial NCT01328301: Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
Official title: Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: gait
hemiplegia
treadmill
physiotherapy
rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tung Wah Hospital
First posted: 2011-04-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in Walking speed
timeFrame: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
measure: change in stride length
timeFrame: Change in stride length from baseline to post-treatment, an expected average of 2 weeks
measure: change in cadence
timeFrame: Change in cadence from baseline to post-treatment, an expected average of 2 weeks
Secondary outcomes:
measure: change in Berg's balance score
timeFrame: Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Margaret Mak
state: Hong Kong
Study officials:
affiliation: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
name: Margaret KY Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References: