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• Cerebrovascular Disease Clinical Trials

Body weight-supported treadmill (BWST) training is an emerging modality to improve walking, but there is limited evidence to support its value. The Locomotor Experience Applied Post-Stroke (LEAPS; NCT00243919) trial was a single-blinded, Phase III, randomized clinical trial that was conducted to provide evidence to guide poststroke walking recovery programs. Pamela W. Duncan, PhD, Duke University, Durham, North Carolina, presented the results.

The objective of the LEAPS trial was to determine if, in addition to usual care, a specialized locomotor training program (LTP) that includes BWST training is superior to a home physical therapy program that is focused on structured, progressive strength and balance exercises (HEP); if the timing of intervention delivery for LTP (Early-LTP at 2 months after stroke vs Late-LTP at 6 months after stroke) affects recovery; and if initial walking impairment severity (moderate vs severe) affects response to the interventions. The primary outcome was the proportion of each group that improved their walking ability by one functional level at 1 year poststroke. The protocol for this study was previously published [Duncan PW et al. BMC Neurol 2007].

The LEAPS study was comprised of adults with moderate or severe walking limitations within 30 days of stroke onset who were able to pass an exercise stress test. Study participants (n=408) were stratified by moderate (0.4 to <0.8 m/sec) or severe (≤0.4 m/sec) walking impairment at 2 months poststroke and were randomly assigned to LTP, including BWST training, starting at either 2 months (Early-LTP; n=139) or 6 months poststroke (Late-LTP; n=143) or a home physical therapist-managed exercise program (HEP; n=126) delivered at 2 months poststroke. Each intervention included 36 sessions of 90 minutes each over 12 to 16 weeks.

Subjects had a mean age of 62 years, and 45% were women. The modified Rankin scale score for 99.5% of patients was 2–4. The mean walking speed was 0.38+0.22 m/sec, and the median number of daily steps was 1738; 53.4% of subjects had severe walking impairment.

At 1 year, ∼52.0% of all participants had improved their walking ability by one functional level. No differences were found in the proportion that improved with Early-LTP or Late-LTP versus HEP. Six months after stroke, Early-LTP and HEP had similar gains in walking speed (Early-LTP 0.25+0.21m/sec; HEP 0.23+0.20 m/sec), which were sustained at 1 year. The Late-LTP group (which received only usual care from Month 2 to Month 6) improved by 0.13+0.14 m/sec at 6 months. All groups achieved similar and highly clinically relevant improvements in 6-minute walking ability, Stroke Impact Scale (SIS), activities of daily living (ADL) and instrumental activities of daily living (IADL) at 1 year.

Ten related serious adverse events were reported (2.2%, 3.5%, and 1.6 % in Early-LTP, Late-LTP, and HEP groups, respectively). There were more multiple falls in the severe Early-LTP group (p<0.07) and more dizziness/faintness during treatment (p<0.01) in the LTP groups. The HEP group had fewer all-cause rehospitalizations (p<0.09).

“LTP is not superior to HEP. Both physical therapy interventions are effective and have a low risk of adverse events, but HEP is associated with fewer risks and fewer rehospitalizations and is more accessible and feasible in current practice,” Dr. Duncan said.

• © 2011 MD Conference Express