Use the Back button in your browser to see the other results of your search or to select another record.
Hull early walking aid for rehabilitation of transtibial amputees -- randomized controlled trial (HEART) |
Mazari FA, Mockford K, Barnett C, Khan JA, Brown B, Smith L, Polman RC, Hancock A, Vanicek NK, Chetter IC |
Journal of Vascular Surgery 2010 Dec;52(6):1564-1571 |
clinical trial |
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
PURPOSE: To compare articulated and nonarticulated early walking aids (EWAs) for clinical and quality-of-life outcomes in transtibial amputees. METHODS: Patients undergoing lower limb amputation in a tertiary-care vascular surgical unit were screened over a 4-year period. Recruited patients were randomized to receive articulated amputee mobility aid (AMA) or nonarticulated pneumatic postamputation mobility aid (PPAMA) during early rehabilitation. Primary (10-meter walking velocity) and secondary clinical (number and duration of physiotherapy treatments during EWA/prosthesis use) and quality-of-life (SF-36) outcome measures were recorded at five standardized assessment visits. Inter-group and intra-group analyses were performed. RESULTS: Two hundred seventy-two patients were screened and 29 transtibial amputees (median age 56 years) were recruited (14/treatment arm). No significant difference was seen in demographics and comorbidities at baseline. Inter-group analysis: Median 10-meter walking velocity was significantly (Mann-Whitney, p = 0.020) faster in the PPAMA group (0.245 m/s, interquartile range (IQR) 0.218 to 0.402 m/s) compared with the AMA group (0.165 m/s; IQR 0.118 to 0.265 m/s) at visit 1. However, there was no difference between the groups at any other visit. Similarly, the number of treatments using EWA was significantly (p = 0.045) lower in the PPAMA group (5.0; IQR 3.5 to 8.0) compared with the AMA group (6.0; IQR 6.0 to 10.5). No difference was observed between the groups in duration of physiotherapy or SF-36 domain and summary scores. Intra-group analysis: Both treatment groups showed significant improvement in 10-meter walking velocity (Friedman test; AMA p = 0.001; PPAMA p = 0.007); however, other clinical outcomes did not show any statistically significant improvement. Only physical function domain of SF-36 demonstrated significant improvement (Friedman test; AMA p = 0.037; PPAMA p = 0.029). CONCLUSIONS: There is no difference in clinical and QOL outcomes between articulated and nonarticulated EWAs in rehabilitation of transtibial amputees.
|