Telemedicine Program in Parkinson's Disease (TELEPARK)

Parkinson's Disease Clinical Trial

— TELEPARK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02827812
• Other study ID #: 1_neuro_veruno
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2016
• Last updated: July 8, 2016
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Comprehensive evaluation
At baseline (T0) and after 3-months (T1) all patients will be evaluated with Scales and questionnaire.
• 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.
• Home-Based telemedicine program
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. A physiotherapist-tutor will supervise the patient's home-based individualized rehabilitation program, through scheduled videoconferences.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

References & Publications (6)

Arcolin I, Pisano F, Delconte C, Godi M, Schieppati M, Mezzani A, Picco D, Grasso M, Nardone A. Intensive cycle ergometer training improves gait speed and endurance in patients with Parkinson's disease: A comparison with treadmill training. Restor Neurol — View Citation

Biglan KM, Voss TS, Deuel LM, Miller D, Eason S, Fagnano M, George BP, Appler A, Polanowicz J, Viti L, Smith S, Joseph A, Dorsey ER. Telemedicine for the care of nursing home residents with Parkinson's disease. Mov Disord. 2009 May 15;24(7):1073-6. doi: 1 — View Citation

Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2. — View Citation

Samii A, Ryan-Dykes P, Tsukuda RA, Zink C, Franks R, Nichol WP. Telemedicine for delivery of health care in Parkinson's disease. J Telemed Telecare. 2006;12(1):16-8. — View Citation

Scalvini S, Zanelli E, Comini L, Dalla Tomba M, Troise G, Febo O, Giordano A. Home-based versus in-hospital cardiac rehabilitation after cardiac surgery: a nonrandomized controlled study. Phys Ther. 2013 Aug;93(8):1073-83. doi: 10.2522/ptj.20120212. Epub — View Citation

Schwab S, Vatankhah B, Kukla C, Hauchwitz M, Bogdahn U, Fürst A, Audebert HJ, Horn M; TEMPiS Group. Long-term outcome after thrombolysis in telemedical stroke care. Neurology. 2007 Aug 28;69(9):898-903. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants in the PTE group who will concluded the home-based program.	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	No
Secondary	Improvement of quality of life (QoL) measured by the "Parkinson's disease questionnaire" (PDQ-39)	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)	No
Secondary	Improvement of exercise tolerance capacity measured in the meters walked, by the 6-min walk test (6MWT)		Difference between two groups of 6MWT measured at baseline (T0) and after 3 months (T1)	No
Secondary	Improvement of balance measured by Balance Evaluation Systems Test (Mini BesTest)	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)	No