Is Remote Physiotherapy Effective for People With Early Parkinson's (PEEP)

NCT04389138 | Unknown

• 1 other identifier: DHRD/2018/104
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Parkinson's disease is a progressive neurodegenerative condition affecting 145,500 people in the UK. The condition impairs movement leading to gait and dexterity problems. Various types of exercise are beneficial for both motor and non-motor symptoms such as depression. The World Health Organisation's (WHO) recommendations on exercise include at least 150 minutes of moderate-intensity aerobic physical activity per week . People with Parkinson's may struggle to achieve this because of movement problems and fatigue. Physiotherapists may have a role in persuading people to exercise and supporting them in their activity goals. While studies show that Parkinson's patients with falls or gait freezing clearly benefit form physiotherapy, there is at present no robust evidence to demonstrate the impact of physiotherapy early in the course of the illness. PEEP seeks to explore the effectiveness of physiotherapy for early Parkinson's (ie within 4 years of diagnosis and before onset of falls). It comprises three distinct parts:

1. 1.A survey of people with Parkinson's exploring their experience and opinions with respect to physiotherapy for early Parkinson's
2. 2.A feasibility randomised controlled trial (fRCT)
3. 3.A qualitative process evaluation. The fRCT will aim to recruit and randomise 40 people withParkinson's who have been diagnosed in the last 4 years and have had no physiotherapy. These participants will undergo several assessments at baseline, 3 months and 6 months, and will also have 7 days' worth of activity monitoring done via physical diary and a commercially available activity tracker to determine levels of activity. Participants randomised to the intervention arm will also receive 5 physiotherapy sessions (1 for assessment and 4 for treatment) additional to standard NHS care.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (9)

• Number of Eligible Patients

  Screening data will be collected to understand how many participants are eligible for the study. This data is a feasibility outcome which will be used to determine if a larger scale definitive study is possible. The data collected surrounding number of eligible patients can help to power in any future study.

  Collected up to 104 weeks.

• Length of waiting time from enrolment to delivery of intervention.

  Measurement of time between consent and the completion of the physiotherapy intervention. This will be considered a feasibility outcome to determine whether the intervention is feasible for a larger definitive study.

  Collected up to 130 weeks.

• Change from baseline to follow up time points for all clinical outcomes

  The change in all clinical outcomes from baseline to 6 months, the standard deviation, and the effect size of clinical outcomes to define the primary outcome for a future definitive trial.

  Collected up to 130 weeks.

• Completeness of data collection for clinical outcomes.

  Percentage of data completeness will be collected as a feasibility outcome to determine if clinical outcomes can be used in a definitive study

  Collected up to 130 weeks.

• Adherence of clinical staff to intervention protocol.

  This outcome will assess whether the planned number of physiotherapy treatment sessions (4) and follow up telephone consultations (2) are undertaken. A bespoke checklist will be used to document each phone call and physiotherapy visit to outline that the intervention has been delivered.

  Collected up to 130 weeks

• Whether the person assessing the clinical outcomes at baseline, 3 month and 6 month outcomes is blinded

  This will be self reported by the clinician to indicate if the blind was broken. This will be used as a feasibility outcome to determine if any future definitive study can be blinded

  Collected up to 130 weeks.

• Feasibility of Using Activity Monitor

  • Practicalities (including time taken to retrieve and record data) of using commercially available activity monitors as an outcome measure.

  Collected up to 130 weeks.

• Feasibility and Acceptability of Study Intervention through Qualitative interviews with staff and Clinicians working on study.

  Interviews will cover the following topics to assist in determining if a definitive future trial is feasible. * The different elements of usual care in two centres, including use of physiotherapy. * Time needed for research nurse to complete and record all study assessments and outcomes as assessed by qualitative interview. * Recruitment rate. Describe reasons patients chose not take part. * Feedback from the clinicians delivering the intervention about which elements of the intervention could be delivered in a large RCT, the optimal number of patient-therapist interactions and appropriateness of outcomes. * Delivery of the proposed intervention by the physiotherapy services at baseline assessment, follow up visits, telephone reviews.

  Collect

• Feasibility and Acceptability of Study Intervention through Qualitative interviews with participants who participated in the study.

  Purpose of the interviews is to determine if a future definitive trial is feasible and acceptable for participants. Interviews will cover the following topics. * Patient adherence to visit and treatment schedule. Facilitators and barriers for attending the visits and undertaking the required treatment. * Feedback from the patients about the acceptability of the treatment programme and the study assessments.

  Collected up to 130 weeks

Secondary Outcomes (9)

• Parkinson's Disease Questionnaire 39 (PDQ-39)

  Collected at Baseline, 3 and 6 month follow up

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Collected at Baseline, 3 and 6 month follow up

• Activity

  Collected up to 6 months.

• Activity Monitor Data

  Collected up to 6 months.

• Short Form 12 (SF12)

  Collected at baseline, 3 and 6 month follow up visit

Study Arms (2)

Comparison

NO INTERVENTION

In this arm participants will attend 3 study visits to complete study questionnaire and assessments. In between these visits, participants will be asked to wear an activity monitor and record an activity diary for one week. Other than this, participants will continue to receive only standard of care treatment.

Intervention arm

EXPERIMENTAL

In this arm participants will attend the same 3 study visits to complete study questionnaires and assessments. Participants will be asked to wear an acitvity monitor and record an activity diary for one week after the study visits. In between baseline and 6 month follow up, intervention arm participants will receive study physiotherapy. This will consist of an individual assessment and 4 additional sessions of physiotherapy.

Other: Physiotherapy Intervention

Interventions

Physiotherapy Intervention OTHER

Physiotherapy intervention will include an assessment to identify individual areas that physiotherapy should target. Intervention will be based on the core areas recommended by the European Physiotherapy Guideline for Parkinson's Disease: physical capacity (muscle power, tone, joint range of movement, exercise tolerance and pain), transfers, manual dexterity, balance and gait. Posture is incorporated as part of these 5 core areas. The intervention will be delivered over 4 visits.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with Parkinson's aged \>18, diagnosed within the last 4 years.
• Able to read and write English.
• Willing to take part in survey.
• Feasibility RCT
• Parkinson's disease diagnosed \<4 years before study entry
• Parkinson's diagnoses fits UK Brain Bank criteria
• Age ≥18 years at study entry
• Willingness to attend for physiotherapy interventions
• Ability to transfer and walk independently
• Stable Parkinson's medication:
• Parkinson's medication not commenced or altered in last 2 months.
• Changes to Parkinson's medication are not planned/scheduled in next 6 months
• Participants not on PD medication can be recruited. (Treating clinicians can change Parkinson's medication during study according to clinical need and changes will be recorded on case report form.)
• Qualitative process evaluation
• Participants of the feasibility RCT

You may not qualify if:

• Hoehn-Yahr stage 4-5 (Hoehn -Yahr staging included as Appendix 2)
• Lacks capacity to consent
• Meets the criteria for commencement of the Gold Standards Framework (see Appendix 3)
• Falls \[more than 1 fall in the 3 months prior to enrolment\]
• Freezing of gait
• Already had outpatient (OP) or community physiotherapy for Parkinson's:

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert Skelly

  University Hospitals of Derby and Burton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Davis

CONTACT

01332 724736; daniel.davis6@nhs.net

Rob Skelly

CONTACT

rob.skelly@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 15, 2020
• Study Start: May 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share