NIHR Signal ‘Low dose’ physiotherapy and occupational therapy found ineffective for people with mild to moderate Parkinson’s disease

Published on 23 March 2016

Physiotherapy and occupational therapy do not help people with mild to moderate Parkinson’s disease to lead more independent lives. This NIHR-funded randomised controlled trial of adults with Parkinson’s disease did not find any difference between the therapy group and a no-therapy control group at up to 15 months in any of the four measures of activities of daily living: mobility, kitchen activities, domestic tasks or leisure activities.

The average ‘dose’ of the therapies was four sessions of 58 minutes over eight weeks for both therapies combined. The number and intensity of treatment sessions was less than found in some recent trials, but are reflective of current NHS practice. The researchers suggest that future research could investigate more intensive physiotherapy and occupational therapy programmes, and focus on people with more severe Parkinson’s disease.

‘Low dose’ physiotherapy and occupational therapy found ineffective for people with mild to moderate Parkinson’s disease

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Why was this study needed?

Parkinson’s disease is a progressive neurological disorder associated with significant problems with movement, including trembling, stiffness, slowness and loss of balance. It is one of the most common causes of disability in older people. It is estimated that around 1 in 500 people are affected by Parkinson’s, which means there are about 127,000 people in the UK with the condition.

Physiotherapy and occupational therapy are routinely offered to people with Parkinson’s to help relieve symptoms and maintain quality of life. However there is limited research evidence about the effectiveness of these treatments. The NIHR funded this study to help the NHS understand whether the therapies in their current form are benefiting patients.

What did this study do?

This trial recruited 762 people at 38 outpatient centres in the UK. Most of the participants had mild to moderate disease. Half of the people were randomised to combined physiotherapy and occupational therapy and the other half received no therapy (they agreed to have their therapies deferred until the end of the trial). There was 15% dropout in the intervention arm and 12% dropout in the control arm.

The physiotherapy and occupational therapy protocol was based on usual NHS practice and was delivered in the community and/or outpatient setting by qualified therapists. Therapy was tailored to each patient’s requirements. The median therapy dose was four sessions of 58 minutes over eight weeks for both therapies combined, with a mean combined total duration of 263 minutes (range of 38 to 1198 minutes). Most physiotherapy was performed in outpatient settings (53%), while most occupational therapy was in community settings (69%).

What did it find?

  • After three months there was no significant difference between the two groups in their ability to live independently. There was a reduction by 1.5 points in the 66 point NEADL (see Definitions) scale (higher scores reflect greater independence in daily activities) in the therapy group compared with a reduction of 1 point in the control group (mean difference 0.5 points, 95% confidence interval −0.7 to 1.7 points). There was also no difference between groups after nine and 15 months.
  • There was no significant difference between groups when subgroup analysis was performed based on: 1) baseline total NEADL score; 2) age; 3) disease severity.
  • No statistically significant difference was seen in any of the individual categories of the NEADL score: 1) mobility; 2) kitchen activities; 3) domestic tasks; 4) leisure activities.

What does current guidance say on this issue?

The 2006 NICE guideline on Parkinson’s disease recommends that physiotherapy and occupational therapy should be available for all people with Parkinson’s disease regardless of disease stage

What are the implications?

These results do not support the use of low-dose, patient-centred, goal-directed physiotherapy and occupational therapy in patients in the early stages of Parkinson’s disease. The therapies delivered in the trial reflect routine NHS practice, and therapy content was in keeping with guidelines on physiotherapy and occupational therapy. The results are therefore likely to be applicable to many current NHS services. Importantly however, the intensity and number of treatment sessions were low compared to some recent trials.

It should be noted that most of the participants in this trial had mild to moderate disease, so the results may not apply to people with more severe disease. Future research could evaluate more intensive therapy programs for patients with all stages of Parkinson’s disease.

Citation and Funding

Clarke CE, Patel S, Ives N, et al. Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2016; 19:1-10.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (Project number 07/01/07). The University of Birmingham Clinical Trials Unit also received support from the UK Department of Health up to March 2012. Charmaine Meek, MPhil (University of Birmingham, Birmingham, England) was funded through Dr Sackley’s National Institute for Health Research Senior Investigator award and West Midlands Strategic Health Authority Clinical Academic Training award.

Bibliography

Deane K, Ellis-Hill C, Dekker K, et al. A survey of current occupational therapy practice for Parkinson’s disease in the United Kingdom. Br J Occup Ther. 2003;66:193-200.

Deane K, Ellis-Hill C, Dekker K, et al. A Delphi survey of best practice occupational therapy practice for Parkinson’s disease in the United Kingdom.Br J Occup Ther. 2003;66:247-254.

National Collaborating Centre for Chronic Conditions. Parkinson’s disease: National clinical guideline for diagnosis and management in primary and secondary care. London: Royal College of Physicians; 2006.

NHS Choices. Parkinson's disease. London: Department Of Health; 2015.

NICE. Parkinson's disease in over 20s: diagnosis and management. CG35. London: National Institute for Health and Care Excellence; 2006.

Plant RP, Jones D, Ashburn A, et al. Evaluation of Physiotherapy in Parkinson’s Disease: Project Update: The Science and Practice of Multidisciplinary Care in Parkinson’s Disease and Parkinsonism. London: British Geriatric Society; 1999.

Why was this study needed?

Parkinson’s disease is a progressive neurological disorder associated with significant problems with movement, including trembling, stiffness, slowness and loss of balance. It is one of the most common causes of disability in older people. It is estimated that around 1 in 500 people are affected by Parkinson’s, which means there are about 127,000 people in the UK with the condition.

Physiotherapy and occupational therapy are routinely offered to people with Parkinson’s to help relieve symptoms and maintain quality of life. However there is limited research evidence about the effectiveness of these treatments. The NIHR funded this study to help the NHS understand whether the therapies in their current form are benefiting patients.

What did this study do?

This trial recruited 762 people at 38 outpatient centres in the UK. Most of the participants had mild to moderate disease. Half of the people were randomised to combined physiotherapy and occupational therapy and the other half received no therapy (they agreed to have their therapies deferred until the end of the trial). There was 15% dropout in the intervention arm and 12% dropout in the control arm.

The physiotherapy and occupational therapy protocol was based on usual NHS practice and was delivered in the community and/or outpatient setting by qualified therapists. Therapy was tailored to each patient’s requirements. The median therapy dose was four sessions of 58 minutes over eight weeks for both therapies combined, with a mean combined total duration of 263 minutes (range of 38 to 1198 minutes). Most physiotherapy was performed in outpatient settings (53%), while most occupational therapy was in community settings (69%).

What did it find?

  • After three months there was no significant difference between the two groups in their ability to live independently. There was a reduction by 1.5 points in the 66 point NEADL (see Definitions) scale (higher scores reflect greater independence in daily activities) in the therapy group compared with a reduction of 1 point in the control group (mean difference 0.5 points, 95% confidence interval −0.7 to 1.7 points). There was also no difference between groups after nine and 15 months.
  • There was no significant difference between groups when subgroup analysis was performed based on: 1) baseline total NEADL score; 2) age; 3) disease severity.
  • No statistically significant difference was seen in any of the individual categories of the NEADL score: 1) mobility; 2) kitchen activities; 3) domestic tasks; 4) leisure activities.

What does current guidance say on this issue?

The 2006 NICE guideline on Parkinson’s disease recommends that physiotherapy and occupational therapy should be available for all people with Parkinson’s disease regardless of disease stage

What are the implications?

These results do not support the use of low-dose, patient-centred, goal-directed physiotherapy and occupational therapy in patients in the early stages of Parkinson’s disease. The therapies delivered in the trial reflect routine NHS practice, and therapy content was in keeping with guidelines on physiotherapy and occupational therapy. The results are therefore likely to be applicable to many current NHS services. Importantly however, the intensity and number of treatment sessions were low compared to some recent trials.

It should be noted that most of the participants in this trial had mild to moderate disease, so the results may not apply to people with more severe disease. Future research could evaluate more intensive therapy programs for patients with all stages of Parkinson’s disease.

Citation and Funding

Clarke CE, Patel S, Ives N, et al. Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2016; 19:1-10.

This project was funded by the National Institute for Health Research Health Technology Assessment programme (Project number 07/01/07). The University of Birmingham Clinical Trials Unit also received support from the UK Department of Health up to March 2012. Charmaine Meek, MPhil (University of Birmingham, Birmingham, England) was funded through Dr Sackley’s National Institute for Health Research Senior Investigator award and West Midlands Strategic Health Authority Clinical Academic Training award.

Bibliography

Deane K, Ellis-Hill C, Dekker K, et al. A survey of current occupational therapy practice for Parkinson’s disease in the United Kingdom. Br J Occup Ther. 2003;66:193-200.

Deane K, Ellis-Hill C, Dekker K, et al. A Delphi survey of best practice occupational therapy practice for Parkinson’s disease in the United Kingdom.Br J Occup Ther. 2003;66:247-254.

National Collaborating Centre for Chronic Conditions. Parkinson’s disease: National clinical guideline for diagnosis and management in primary and secondary care. London: Royal College of Physicians; 2006.

NHS Choices. Parkinson's disease. London: Department Of Health; 2015.

NICE. Parkinson's disease in over 20s: diagnosis and management. CG35. London: National Institute for Health and Care Excellence; 2006.

Plant RP, Jones D, Ashburn A, et al. Evaluation of Physiotherapy in Parkinson’s Disease: Project Update: The Science and Practice of Multidisciplinary Care in Parkinson’s Disease and Parkinsonism. London: British Geriatric Society; 1999.

Physiotherapy and Occupational Therapy vs No Therapy in Mild to Moderate Parkinson Disease. A Randomized Clinical Trial

Published on 19 January 2016

Clarke C, Patel S, Ives N, Rick C, Dowling F, Wooley R, Wheatley K, Walker M, Sackley C,

JAMA Neurology , 2016

Importance It is unclear whether physiotherapy and occupational therapy are clinically effective and cost-effective in Parkinson disease (PD). Objective To perform a large pragmatic randomized clinical trial to evaluate the clinical effectiveness of individualized physiotherapy and occupational therapy in PD. Design, Setting, and Participants The PD REHAB Trial was a multicenter, open-label, parallel group, controlled efficacy trial. A total of 762 patients with mild to moderate PD were recruited from 38 sites across the United Kingdom. Recruitment took place between October 2009 and June 2012, with 15 months of follow-up. Interventions Participants with limitations in activities of daily living (ADL) were randomized to physiotherapy and occupational therapy or no therapy. Main Outcomes and Measures The primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) Scale score at 3 months after randomization. Secondary outcomes were health-related quality of life (assessed by Parkinson Disease Questionnaire–39 and EuroQol-5D); adverse events; and caregiver quality of life. Outcomes were assessed before trial entry and then 3, 9, and 15 months after randomization. Results Of the 762 patients included in the study (mean [SD] age, 70 [9.1] years), 381 received physiotherapy and occupational therapy and 381 received no therapy. At 3 months, there was no difference between groups in NEADL total score (difference, 0.5 points; 95% CI, −0.7 to 1.7; P = .41) or Parkinson Disease Questionnaire–39 summary index (0.007 points; 95% CI, −1.5 to 1.5; P = .99). The EuroQol-5D quotient was of borderline significance in favor of therapy (−0.03; 95% CI, −0.07 to −0.002; P = .04). The median therapist contact time was 4 visits of 58 minutes over 8 weeks. Repeated-measures analysis showed no difference in NEADL total score, but Parkinson Disease Questionnaire–39 summary index (diverging 1.6 points per annum; 95% CI, 0.47 to 2.62; P = .005) and EuroQol-5D score (0.02; 95% CI, 0.00007 to 0.03; P = .04) showed small differences in favor of therapy. There was no difference in adverse events. Conclusions and Relevance Physiotherapy and occupational therapy were not associated with immediate or medium-term clinically meaningful improvements in ADL or quality of life in mild to moderate PD. This evidence does not support the use of low-dose, patient-centered, goal-directed physiotherapy and occupational therapy in patients in the early stages of PD. Future research should explore the development and testing of more structured and intensive physical and occupational therapy programs in patients with all stages of PD.

The main outcome in this study was change in NEADL (Nottingham Extended Activities of Daily Living) Score. The scale is a telephone or postal questionnaire that gives a score from 0 to 66, with a higher score describing greater independence in daily living. People’s ability to perform everyday tasks is assessed across four domains: 1) mobility; 2) kitchen activities; 3) domestic tasks; 4) leisure activities.

Expert commentary

From this study’s limited data it would be misleading to say physiotherapy and occupational therapy don’t improve the lives of people with Parkinson’s.

There is considerable evidence that these therapies help people with Parkinson’s. Last year a study found significant improvement following up to 16 hours of occupational therapy over 10 weeks. In comparison, the current study involved just four hours of therapy over eight weeks.

While we do need more investigation into the best way to deliver these therapies, there is no question that they must continue to be provided to the 127,000 people affected across the UK.

Daiga Heisters, Head of the UK Parkinson’s Excellence Network