Hull early walking aid for rehabilitation of transtibial amputees--randomized controlled trial (HEART).
OBJECTIVE
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 = .020) faster in the PPAMA group (0.245 m/s, interquartile range [IQR] 0.218-0.402 m/s) compared with the AMA group (0.165 m/s; IQR, 0.118-0.265 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 = .045) lower in the PPAMA group (5.0; IQR, 3.5-8.0) compared with the AMA group (6.0; IQR, 6.0-10.5). 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 = .001; PPAMA P = .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 = .037; PPAMA P = .029).


CONCLUSIONS
There is no difference in clinical and QOL outcomes between articulated and nonarticulated EWAs in rehabilitation of transtibial amputees.
Mazari
Fayyaz Ali Khan
FA
Academic Vascular Surgery Unit, University of Hull, Hull, United Kingdom. fayyaz.mazari@hey.nhs.uk
Mockford
Katherine
K
Barnett
Cleveland
C
Khan
Junaid A
JA
Brown
Barbara
B
Smith
Lynne
L
Polman
Remco C
RC
Hancock
Amanda
A
Vanicek
Natalie K
NK
Chetter
Ian C
IC
D000328:Adult; D000368:Aged; D000671:Amputation, Surgical / Q000534:rehabilitation*; D001186:Artificial Limbs; D004434:Early Ambulation; D005260:Female; D006801:Humans; D007866:Leg / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D026741:Physical Therapy Modalities; D011474:Prosthesis Design; D011788:Quality of Life; D013977:Tibia; D016138:Walking