Telemedicine Program in Parkinson's Disease (TELEPARK) (TELEPARK)

July 8, 2016 updated by: Fabrizio Pisano, Fondazione Salvatore Maugeri

Home-Based Telesurveillance and Rehabilitation Program in Parkinson's Disease: Pilot Randomized Trial

Parkinson's disease (PD) is a chronic neurodegenerative disease due to the loss of dopaminergic neurons in the substantia nigra, leading to motor symptoms of tremor, rigidity, and bradykinesia, as well as an array of non-motor symptoms that affect cognition, sleep, behaviour, and the autonomic nervous system.

Lifelong rehabilitation measures, along with medication treatment, are the major components of patient management. Physical exercises positively affect patients' quality of life (QOL) and their functional capacities. Poor adherence to rehabilitation, limited patient education, and access to specialized care can be barriers to treatment. A number of papers in fact report that telemedicine is an acceptable means of care delivery reduces travel burdens and may improve patient outcomes. However, most of these studies were not randomized or controlled and did not include nursing home patients, who may benefit the most from specialty care.

Moreover, there is no evidence supporting the use of telerehabilitation for physical assessments of people with PD. For this reason investigators hypothesize that a home telerehabilitation system guiding patients in following their exercise program combined with a computerized decision-support tool monitoring patient performance, would be feasible for and acceptable to patients with PD and would improve functional status.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim of the study:

  1. Demonstrate the feasibility of at home telesurveillance and rehabilitation program
  2. Demonstrate the effectiveness of the program in improving quality of life and functional aspects in patients affected by Parkinson's disease

30 patients affected by Parkinson's disease (PD), will be consecutively screened. The method of sequence generation relied on a computerized random number generator. The person who allocated patients to the two groups was not involved either in treatment or in evaluation of the patients.

The study was submitted for approval of the Central Ethics Review Board. Participants will be randomly assigned to two different groups of training using a random number table to receive either telemedicine care (PTE) or their usual care (PUC).

All the patients will receive in our Institute a comprehensive baseline evaluation conducted by both the neurologist and the physical therapist specialized in the treatment of PD.

During the baseline evaluation (T0), both PTE and PUC will perform two supervised familiarization sessions using the same training protocol to be used once at home.

Caregivers are an essential part in the PD patients' home management and rehabilitation and they therefore will be involved in all educational stages.

Each patient of both groups will receive two types of physical intervention:

  1. A traditional custom-tailored rehabilitative exercise program; he will be trained by the therapist on how to perform the exercises. These exercises will include functional strengthening, stretching, postural changes and balance activities
  2. An aerobic training All patients will be asked to perform these exercises for 60 minutes 3 days/week for three months.

The training phase will last 20 minutes during the first month and 30 minutes over the second and third month; Training intensity could be progressively increased over the three months of intervention, Aerobic training familiarization sessions will be performed on the same ergometer they will receive for home-based training.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30 patients affected by Parkinson's disease (PD), according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria (Hughes et al.,1992), will be consecutively screened. Participants should have a Hoehn & Yahr stage between 1,5 and 3. All subjects will be on stabilized treatment with L-dopa or dopamine agonists.

All participants will provide written informed consent to the study.

Exclusion Criteria:

  • inability to participate in the exercise programs, other neurological conditions in addition to PD, psychiatric complications or personality disorders, musculoskeletal or cardiopulmonary conditions affecting mobility, and non-consent to participate in the study A cognitive impairment scores measured with Mini Mental State Examination (MMSE) ≤ 26/30.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Participants Telemedicine Care (PTE)

A. Comprehensive evaluation at baseline (T0) and at the end of the study (T1).

B. Physical Intervention at home for 60 minutes 3 days/week for three months

C. Home-Based telemedicine program:
Other: Comprehensive evaluation
At baseline (T0) and after 3-months (T1) all patients will be evaluated with Scales and questionnaire.
Other: Physical Intervention at home
A traditional custom-tailored rehabilitative exercise program. The exercises will include functional strengthening, stretching, postural changes and balance activities; - An aerobic training on a cycle ergometer 3 days /week for three months.
Other: Home-Based telemedicine program
  1. A nurse-tutor will follow patients through structured telephone appointments, collecting information about disease status and symptoms, offering advice regarding diet, lifestyle and medications and suggesting changes in therapy, according with the neurologist. The patient's clinical data and any suggestions made will be filled in a personal health electronic record.
  2. A physiotherapist-tutor will supervise the patient's home-based individualized rehabilitation program, through scheduled videoconferences.
ACTIVE_COMPARATOR: Participants Usual Care (PUC)

A. Comprehensive evaluation at baseline (T0) and at the end of the study (T1).

B. Physical Intervention at home for 60 minutes 3 days/week for three months
Other: Comprehensive evaluation
At baseline (T0) and after 3-months (T1) all patients will be evaluated with Scales and questionnaire.
Other: Physical Intervention at home
A traditional custom-tailored rehabilitative exercise program. The exercises will include functional strengthening, stretching, postural changes and balance activities; - An aerobic training on a cycle ergometer 3 days /week for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants in the PTE group who will concluded the home-based program.
Time Frame: Through study completion, an average of 3 months
The program is feasible if at least 80% of participants in the PTE group complete the home program lasting 3 months. The participant completes the home program if carries out at least 50% of the prescribed physical activity.
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of quality of life (QoL) measured by the "Parkinson's disease questionnaire" (PDQ-39)
Time Frame: Difference between two groups of PDQ-39 measured at baseline (T0) and after 3 months (T1)
The PDQ consider eight discrete scales on mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items) and bodily discomfort (3 items). Participants are asked to indicate the frequency of each event by selecting one of 5 options (from never to always). Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL
Difference between two groups of PDQ-39 measured at baseline (T0) and after 3 months (T1)
Improvement of exercise tolerance capacity measured in the meters walked, by the 6-min walk test (6MWT)
Time Frame: Difference between two groups of 6MWT measured at baseline (T0) and after 3 months (T1)
Difference between two groups of 6MWT measured at baseline (T0) and after 3 months (T1)
Improvement of balance measured by Balance Evaluation Systems Test (Mini BesTest)
Time Frame: Difference between two groups of Mini BesTest measured at baseline (T0) and after 3 months (T1)
The Mini-BESTest includes 14 items representing four domains of dynamic balance:anticipatory postural adjustments (items 1-3), postural responses (items 4-6), sensory orientation (items 7-9) and balance during gait (items 10-14). The Mini-BESTest items are rated on a 3-point scale from 0 to 2 and the total score ranges from 0 to 28 with a higher score indicating better balance performance.
Difference between two groups of Mini BesTest measured at baseline (T0) and after 3 months (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Salvatore Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

July 1, 2016

First Submitted That Met QC Criteria

July 8, 2016

First Posted (ESTIMATE)

July 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 8, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1_neuro_veruno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Comprehensive evaluation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe