The PIT: SToPP Trial—A Feasibility Randomised Controlled Trial of Home-Based Physiotherapy for People with Parkinson's Disease Using Video-Based Measures to Preserve Assessor Blinding
Purpose. To trial four-week's physiotherapy targeting chair transfers for people with Parkinson's disease (PwPD) and explore the feasibility of reliance on remote outcome measurement to preserve blinding. Scope. We recruited 47 PwPD and randomised 24 to a focused home physiotherapy programme (exercise, movement strategies, and cueing) and 23 to a control group. We evaluated transfers (plus mobility, balance, posture, and quality of life) before and after treatment and at followup (weeks 0, 4, 8, and 12) from video produced by, and questionnaires distributed by, treating physiotherapists. Participants fed back via end-of-study questionnaires. Thirty-five participants (74%) completed the trial. Excluding dropouts, 20% of questionnaire data and 9% of video data were missing or unusable; we had to evaluate balance in situ. We noted trends to improvement in transfers, mobility, and balance in the physiotherapy group not noted in the control group. Participant feedback was largely positive and assessor blinding was maintained in every case. Conclusions. Intense, focused physiotherapy at home appears acceptable and likely to bring positive change in those who can participate. Remote outcome measurement was successful; questionnaire followup and further training in video production would reduce missing data. We advocate a fully powered trial, designed to minimise dropouts and preserve assessor blinding, to evaluate this intervention. 1. Introduction Chair transfers, a common cause of falls [1, 2], are a key domain of physiotherapy for people with Parkinson’s disease (PwPD) [3–5]. While weak lower limbs and inflexible, unstable trunks extend rising time [6–10], exercise shortens sit-to-stand times and PwPD can relearn motor sequences, facilitating movement through cueing [3, 4, 11–14]. In their 2007 evidence-based analysis of physical therapy in Parkinson’s disease (PD), Keus et al. [3] found supportive evidence for improving the performance of transfers among PwPD in just two studies. The potential to improve transfers among PwPD has been underresearched since Kamsma et al. [11] and Nieuwboer et al. [12] evaluated the use of cognitive movement strategies, the former in a randomised controlled trial (RCT; ), the latter in a nonrandomised controlled trial ( ). Over 12 months, Kamsma et al.’s experimental group (mean age 68 years) practiced a seven-step sequence for safe rising (positioning hands, positioning feet, shifting to the seat edge, repositioning hands, leaning forward, rising into standing, and adopting upright posture), a “logical structure” that
References
[1]
A. Ashburn, E. Stack, C. Ballinger, L. Fazakarley, and C. Fitton, “The circumstances of falls among people with Parkinson's disease and the use of Falls Diaries to facilitate reporting,” Disability and Rehabilitation, vol. 30, no. 16, pp. 1205–1212, 2008.
[2]
E. Stack and A. Ashburn, “Fall events described by people with Parkinson's disease: implications for clinical interviewing and the research agenda,” Physiotherapy Research International, vol. 4, no. 3, pp. 190–200, 1999.
[3]
S. H. J. Keus, B. R. Bloem, E. J. M. Hendriks, A. B. Bredero-Cohen, and M. Munneke, “Evidence-based analysis of physical therapy in Parkinson's disease with recommendations for practice and research,” Movement Disorders, vol. 22, no. 4, pp. 451–460, 2007.
[4]
A. Ashburn, D. Jones, R. Plant, et al., “Physiotherapy for people with PD in the UK: an exploration of practice,” International Journal of Therapy and Rehabilitation, vol. 11, no. 4, pp. 160–167, 2004.
[5]
W. J. Mutch, A. Strudwick, S. K. Roy, and A. W. Downie, “Parkinson's disease: disability, review, and management,” British Medical Journal, vol. 293, no. 6548, pp. 675–677, 1986.
[6]
V. K. Ramsey, T. A. Miszko, and M. Horvat, “Muscle activation and force production in Parkinson's patients during sit to stand transfers,” Clinical Biomechanics, vol. 19, no. 4, pp. 377–384, 2004.
[7]
M. K. Y. Mak, O. Levin, J. Mizrahi, and C. W. Y. Hui-Chan, “Joint torques during sit-to-stand in healthy subjects and people with Parkinson's disease,” Clinical Biomechanics, vol. 18, no. 3, pp. 197–206, 2003.
[8]
L. M. Inkster, J. J. Eng, D. L. MacIntyre, and A. Jon Stoessl, “Leg muscle strength is reduced in Parkinson's disease and relates to the ability to rise from a chair,” Movement Disorders, vol. 18, no. 2, pp. 157–162, 2003.
[9]
M. K. Y. Mak and C. W. Y. Hui-Chan, “Switching of movement direction is central to Parkinsonian bradykinesia in sit-to-stand,” Movement Disorders, vol. 17, no. 6, pp. 1188–1195, 2002.
[10]
E. Nikfekr, K. Kerr, S. Attfield, and D. E. Playford, “Trunk movement in Parkinson's disease during rising from seated position,” Movement Disorders, vol. 17, no. 2, pp. 274–282, 2002.
[11]
Y. P. T. Kamsma, W. H. Brouwer, and J. P. W. F. Lakke, “Training of compensational strategies for impaired gross motor skills in Parkinson's disease,” Physiotherapy Theory and Practice, vol. 11, no. 4, pp. 209–229, 1995.
[12]
A. Nieuwboer, W. de Weerdt, R. Dom, M. Truyen, L. Janssens, and Y. Kamsma, “The effect of a home physiotherapy program for persons with Parkinson's disease,” Journal of Rehabilitation Medicine, vol. 33, no. 6, pp. 266–272, 2001.
[13]
A. Nieuwboer, W. de Weerdt, R. Dom, K. Bogaerts, and G. Nuyens, “Development of an activity scale for individuals with advanced Parkinson disease: reliability and 'on-off' variability,” Physical Therapy, vol. 80, no. 11, pp. 1087–1096, 2000.
[14]
M. K. Y. Mak and C. W. Y. Hui-Chan, “Cued task-specific training is better than exercise in improving sit-to-stand in patients with Parkinson's disease: a randomized controlled trial,” Movement Disorders, vol. 23, no. 4, pp. 501–509, 2008.
[15]
National Institute for Health and Clinical Excellence (NICE), “Parkinson’s Disease: diagnosis and management in primary and secondary care,” Clinical Guideline 35, 2006, www.nice.org.uk/CG035.
[16]
R. W. Poolman, P. A. Struijs, R. Krips et al., “Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?” Journal of Bone and Joint Surgery, Series A, vol. 89, no. 3, pp. 550–558, 2007.
[17]
J. Nocera, M. Horvat, and C. T. Ray, “Effects of home-based exercise on postural control and sensory organization in individuals with Parkinson disease,” Parkinsonism and Related Disorders, vol. 15, no. 10, pp. 742–745, 2009.
[18]
A. Ashburn, L. Fazakarley, C. Ballinger, R. Pickering, L. D. McLellan, and C. Fitton, “A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease,” Journal of Neurology, Neurosurgery and Psychiatry, vol. 78, no. 7, pp. 678–684, 2007.
[19]
D. Jones and J. E. Playfer, “Parkinson’s disease,” in Physical Management for Neurological Conditions, M. Stokes and E. Stack, Eds., chapter 6, Elsevier, 3rd edition, 2011.
[20]
M. M. Hoehn and M. D. Yahr, “Parkinsonism: onset, progression and mortality,” Neurology, vol. 17, no. 5, pp. 427–442, 1967.
[21]
A. J. Hughes, S. E. Daniel, L. Kilford, and A. J. Lees, “Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases,” Journal of Neurology Neurosurgery and Psychiatry, vol. 55, no. 3, pp. 181–184, 1992.
[22]
A. Shiel and B. A. Wilson, “Performance of stroke patients on the Middlesex Elderly Assessment of Mental State,” Clinical Rehabilitation, vol. 6, no. 4, pp. 283–289, 1992.
[23]
E. Stack, K. Jupp, and A. Ashburn, “Developing methods to evaluate how people with Parkinson's Disease turn 180°: an activity frequently associated with falls,” Disability and Rehabilitation, vol. 26, no. 8, pp. 478–484, 2004.
[24]
K. H. O. Deane, C. Ellis-Hill, K. Dekker, P. Davies, and C. E. Clarke, “A survey of current occupational therapy practice for Parkinson's disease in the United Kingdom,” British Journal of Occupational Therapy, vol. 66, no. 5, pp. 193–200, 2003.
[25]
E. Stack and A. Ashburn, “Early development of the Standing-start 180° Turn Test,” Physiotherapy, vol. 91, no. 1, pp. 6–13, 2005.
[26]
P. W. Duncan, D. K. Weiner, J. Chandler, and S. Studenski, “Functional reach: a new clinical measure of balance,” Journals of Gerontology, vol. 45, no. 6, pp. M192–M197, 1990.
[27]
E. Lang and S. Fahn, “Assessment of PD,” in Quantification of Neurologic Deficit, T. Munsat, Ed., chapter 21, Butterworths, Methuen, Mass, USA, 1989.
[28]
R. G. Brown, B. MacCarthy, M. Jahanshahi, and C. D. Marsden, “Accuracy of self-reported disability in patients with parkinsonism,” Archives of Neurology, vol. 46, no. 9, pp. 955–959, 1989.
[29]
T. H. Haapaniemi, K. A. Sotaniemi, H. Sintonen, and E. Taimela, “The generic 15D instrument is valid and feasible for measuring health related quality of life in Parkinson's disease,” Journal of Neurology, Neurosurgery and Psychiatry, vol. 75, no. 7, pp. 976–983, 2004.
[30]
S. H. J. Keus, B. R. Bloem, D. Verbaan et al., “Physiotherapy in Parkinson's disease: utilisation and patient satisfaction,” Journal of Neurology, vol. 251, no. 6, pp. 680–687, 2004.
[31]
B. Caird, “Physiotherapy benefits patients with PD,” Clinical Rehabilitation, vol. 3, pp. 11–16, 1989.
[32]
J. A. K. Moffett and P. H. Richardson, “The influence of the physiotherapist-patient relationship on pain and disability,” Physiotherapy Theory and Practice, vol. 13, no. 1, pp. 89–96, 1997.
[33]
P. K. Schot, K. M. Knutzen, S. M. Poole, and L. A. Mrotek, “Sit-to-stand performance of older adults following strength training,” Research Quarterly for Exercise and Sport, vol. 74, no. 1, pp. 1–8, 2003.
[34]
E. Stack, “Physiotherapy: the ultimate placebo,” Physiotherapy Research International, vol. 11, no. 3, pp. 127–128, 2006.
[35]
S. Fiorucci, A. Mencarelli, A. Meneguzzi et al., “Co-administration of nitric oxide-aspirin (NCX-4016) and aspirin prevents platelet and monocyte activation and protects against gastric damage induced by aspirin in humans,” Journal of the American College of Cardiology, vol. 44, no. 3, pp. 635–641, 2004.
[36]
L. O'Brien, A. Taddio, M. Ipp, M. Goldbach, and G. Koren, “Topical 4% amethocaine gel reduces the pain of subcutaneous measles-mumps-rubella vaccination,” Pediatrics, vol. 114, no. 6, pp. e720–e724, 2004.
[37]
D. Kunkel and E. Stack, “Falls and their Management,” in Physical Management for Neurological Conditions, M. Stokes and E. Stack, Eds., chapter 20, Elsevier, 3rd edition, 2011.
