Journal of Physiotherapy. Key words: Randomized Controlled Trial, Stroke, Physical Therapy, Rehabilitation, Walking

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1 Treadmill walking with body weight support in subacute non-ambulatory stroke improves walking capacity more than overground walking: a randomised trial Catherine M Dean 1, Louise Ada 1, Julie Bampton 1, Meg E Morris 2, Pesi H Katrak 3 and Stephanie Potts 3 1 The University of Sydney, 2 The University of Melbourne, 3 Prince Henry/Prince of Wales Hospital Australia Questions: Is treadmill walking with body weight support during inpatient rehabilitation detrimental to walking quality compared with assisted overground walking? Does it result in better walking capacity, perception of walking or community participation? Design: Analysis of secondary outcomes of a randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis. Participants: 126 patients unable to walk within 4 weeks of a stroke who were undergoing inpatient rehabilitation. Intervention: The experimental group undertook up to 30 minutes of treadmill walking with body weight support via an overhead harness per day while the control group undertook up to 30 minutes of overground walking. Outcome measures: The secondary outcomes were walking quality and capacity, walking perception, community participation and falls. Results: Six months after entering the study, there was no difference between the groups of independent walkers in terms of group walked 57 m further (95% CI 1 to 113) in the 6 min walk than those in the control group. The experimental group (walkers and non-walkers) rated their walking 1 point out of 10 (95% CI 0.1 to 1.9) higher than the control group. There was no difference between the groups in community participation or number of falls. Conclusion: Treadmill training with body weight support results in better walking capacity and perception of walking compared to overground walking without deleterious effects on walking quality. Trial registration: NCT [Dean CM, Ada L, Bampton J, Morris Journal of Physiotherapy Key words: Randomized Controlled Trial, Stroke, Physical Therapy, Rehabilitation, Walking Introduction Journal of Physiotherapy 2010 Vol. 56 Australian Physiotherapy Association

2 Research Method Design Participants, therapists and centres Intervention experimental control Outcome measures 98 Journal of Physiotherapy 2010 Vol. 56 Australian Physiotherapy Association 2010

3 Data analysis a priori p Results Flow of participants, therapists and centres through the trial. Characteristics of participants and centres. Characteristic Participants Exp (n = 64) Randomised (n = 126) Con (n = 62) Lost to follow-up (n = 7) Exp (n = 5) Con (n = 2) Age (yr), mean (SD) 70 (9) 71 (9) 72 (5) 75 (5) Gender, n males (%) 38 (59) 33 (53) 2 (40) 1 (50) Side of hemiplegia, n right (%) 30 (47) 26 (42) 4 (80) 0 (0) Time since stroke at enrolment (days), mean (SD) 18 (8) 18 (7) 22 (4) 9 (0) Sitting balance (0 to 6), mean (SD) 3.1 (1.4) 2.9 (1.3) 1.8 (0.8) 2.5 (0.7) Sensory loss (0 to 2), median (IQR) 1 (0 1) 1 (0 1) 0.5 (0 1.5) 0 and 0 Spasticity (0 to 4), median (IQR) 0 (0 1) 0 (0 1) 0 (0 0) 0 and 2 Neglect (0 to 2), median (IQR) 0 (0 0) 0 (0 1) 0 (0 0) 0 and 2 Centres, n (%) A 25 (39) 25 (40) 1 (20) 0 (0) B 21 (33) 19 (31) 4 (80) 0 (0) C 8 (13) 9 (15) 0 (0) 1 (50) D 4 (6) 3 (5) 0 (0) 1 (50) E 3 (5) 3 (5) 0 (0) 0 (0) F 3 (5) 3 (5) 0 (0) 0 (0) Exp = experimental group, Con = control group Journal of Physiotherapy 2010 Vol. 56 Australian Physiotherapy Association

4 Research Stroke patients screened (n = 1767) Excluded (n = 1641) Month 0 Measured sitting balance, sensory loss, spasticity and neglect Randomised (n = 126) (n = 64) (n = 62) Loss to follow up (n = 5) died before DC (n = 2) died after DC (n = 1) withdrew due to anxiety (n = 2) Experimental group 30 minutes per day of treadmill walking with body weight support until walking or discharge usual rehabilitation Control group 30 minutes per day of overground walking until walking or discharge usual rehabilitation Loss to follow up (n = 2) died before DC (n = 2) Month 6 Measured walking quality, walking capacity, perceived walking ability, community participation, and falls (n = 59) (n = 60) Design and flow of participants through the trial. DC = discharge Compliance with trial method Effect of intervention Discussion 100 Journal of Physiotherapy 2010 Vol. 56 Australian Physiotherapy Association 2010

5 . Mean (SD) or number of participants (%) for each outcome in each group and mean or risk difference (95 % CI) between groups at 6 months after admission to study. Outcome Groups Difference between groups Independent walkers, n (%) Walkers only (n = 78) Exp (n = 64) (71) Con (n = 62) (60) Exp relative to Con RD 11 ( 6 to 27) Walking speed (m/s), mean (SD) 0.57 (0.36) n = 38 Walking stride (cm), mean (SD) 73 (31) n = 38 Walking capacity (m), mean (SD) 240 (130) n = 37 All participants (n = 119) Walking self-rating (0 to 10), mean (SD) 5.0 (2.3) n = 45 AAP (0 to 72), mean (SD) 16 (12) n = 44 Falls, n yes (%) (61) Falls (n), mean (SD) 1.2 (1.5) n = 46 Exp = experimental group, Con = control group; AAP = Adelaide Activities Profile 0.47 (0.28) n = (24) n = (99) n = (2.3) n = (8) n = 49 (51) 1.3 (1.9) n = 49 MD 0.10 ( 0.06 to 0.26) MD 6 ( 7 to 19) MD 57 (1 to 113) MD 1.0 (0.1 to 1.9) MD 1 ( 3 to 5) RD 10 ( 10 to 28) MD 0.1 ( 0.8 to 0.6) Journal of Physiotherapy 2010 Vol. 56 Australian Physiotherapy Association

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