title: Hull early walking aid for rehabilitation of transtibial amputees--randomized controlled trial (HEART).
abstract: 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.
authors.affiliation: Academic Vascular Surgery Unit, University of Hull, Hull, United Kingdom. fayyaz.mazari@hey.nhs.uk
authors.forename: Fayyaz Ali Khan
authors.initials: FA
authors.lastname: Mazari
authors.forename: Katherine
authors.initials: K
authors.lastname: Mockford
authors.forename: Cleveland
authors.initials: C
authors.lastname: Barnett
authors.forename: Junaid A
authors.initials: JA
authors.lastname: Khan
authors.forename: Barbara
authors.initials: B
authors.lastname: Brown
authors.forename: Lynne
authors.initials: L
authors.lastname: Smith
authors.forename: Remco C
authors.initials: RC
authors.lastname: Polman
authors.forename: Amanda
authors.initials: A
authors.lastname: Hancock
authors.forename: Natalie K
authors.initials: NK
authors.lastname: Vanicek
authors.forename: Ian C
authors.initials: IC
authors.lastname: Chetter
mesh_terms: 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