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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389138
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospitals of Derby and Burton NHS Foundation Trust

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. A survey of people with Parkinson's exploring their experience and opinions with respect to physiotherapy for early Parkinson's
  2. A feasibility randomised controlled trial (fRCT)
  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.

Staff and some participants involved in the fRCT will be included in a qualitative process evaluation to assess the acceptability and feasibility of the intervention and the research assessments.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Physiotherapy Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Is Physiotherapy Effective for People With Early Parkinson's (PEEP) a Feasibility Study
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Comparison
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.
Experimental: Intervention arm
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
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.




Primary Outcome Measures :
  1. Number of Eligible Patients [ Time Frame: Collected up to 104 weeks. ]
    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.

  2. Length of waiting time from enrolment to delivery of intervention. [ Time Frame: Collected up to 130 weeks. ]
    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.

  3. Change from baseline to follow up time points for all clinical outcomes [ Time Frame: Collected up to 130 weeks. ]
    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.

  4. Completeness of data collection for clinical outcomes. [ Time Frame: Collected up to 130 weeks. ]
    Percentage of data completeness will be collected as a feasibility outcome to determine if clinical outcomes can be used in a definitive study

  5. Adherence of clinical staff to intervention protocol. [ Time Frame: Collected up to 130 weeks ]
    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.

  6. Whether the person assessing the clinical outcomes at baseline, 3 month and 6 month outcomes is blinded [ Time Frame: Collected up to 130 weeks. ]
    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

  7. Feasibility of Using Activity Monitor [ Time Frame: Collected up to 130 weeks. ]
    • Practicalities (including time taken to retrieve and record data) of using commercially available activity monitors as an outcome measure.

  8. Feasibility and Acceptability of Study Intervention through Qualitative interviews with staff and Clinicians working on study. [ Time Frame: Collect ]

    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.

  9. Feasibility and Acceptability of Study Intervention through Qualitative interviews with participants who participated in the study. [ Time Frame: Collected up to 130 weeks ]

    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.


Secondary Outcome Measures :
  1. Parkinson's Disease Questionnaire 39 (PDQ-39) [ Time Frame: Collected at Baseline, 3 and 6 month follow up ]
    Clinical Outcome collected by Questionnaire. Scored 0-100, 100 is considered the worst outcome.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Collected at Baseline, 3 and 6 month follow up ]
    a global measure of Parkinson's severity that includes subsections looking at motor symptoms and signs, non-motor symptoms, activities of daily living and mood. Lower scores better. 4 subscales: non-motor 0-52, motor experience0-52, motor examination 0-132, motor complication 0-24.

  3. Activity [ Time Frame: Collected up to 6 months. ]
    Activity as captured using Activity diaries: types of activity; total number of minutes per day and per week at different levels of perceived exertion based on Borg scale 620.

  4. Activity Monitor Data [ Time Frame: Collected up to 6 months. ]
    Step count, minutes of sleep (Rem, light, deep) and very & moderately active minutes using Fitbit Inspire HR activity monitors

  5. Short Form 12 (SF12) [ Time Frame: Collected at baseline, 3 and 6 month follow up visit ]
    measuring carer well-being, where a carer is available. Higher scores are better (Better health status). 50 is average score. 40-60 is range within 1 standard deviation of mean score. Scores 30-70 represent scores within 2 standard deviations of mean. There are subscales for Physical health and mental health.

  6. Lindop Parkinson's Assessment Scale [LPAS] [ Time Frame: Collected at baseline, 3 and 6 month follow up visit ]
    Assessment of Gait (LPAS includes Timed up and Go) and transfers (timed bed transfers - included in LPAS)

  7. Mini Balance Evaluation Systems Test (mini-BEST) [ Time Frame: Collected at baseline, 3 and 6 month follow up visits ]
    Questionnaire assessment

  8. Tragus to Wall distance (posture assessment) [ Time Frame: Collected at baseline, 3 and 6 month follow up visits ]
    posture assessment. 10 cm - 12cm range is considered the better range. Higher scores up to 30cm in rare cases suggest worse health outcomes.

  9. Number of Falls [ Time Frame: Collected at baseline , 3 month and 6 month follow up visits. ]
    Self reported outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA Survey of people with Parkinson's

  • 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
  • Physiotherapists within the trial conducting assessments and treatments.
  • Research Nurses who delivered the RCT

EXCLUSION CRITERIA

  • 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:

OP physiotherapy for trauma or arthritis will not be exclusion A single one -off assessment of Parkinson's by a physiotherapist will not be an exclusion Attendance at exercise classes which are not supervised by a physiotherapist will not count as an exclusion.

IP physiotherapy will not count as an exclusion Unable to communicate in English


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389138


Contacts
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Contact: Daniel Davis 01332 724736 ext 24736 daniel.davis6@nhs.net
Contact: Rob Skelly rob.skelly@nhs.net

Sponsors and Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
Investigators
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Principal Investigator: Robert Skelly University Hospitals of Derby and Burton NHS Foundation Trust
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Responsible Party: University Hospitals of Derby and Burton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04389138    
Other Study ID Numbers: DHRD/2018/104
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases