Clinical trial NCT02827812: Telemedicine Program in Parkinson's Disease (TELEPARK)
Official title: Home-Based Telesurveillance and Rehabilitation Program in Parkinson's Disease: Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants in the PTE group who will concluded the home-based program.
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Improvement of quality of life (QoL) measured by the "Parkinson's disease questionnaire" (PDQ-39)
timeFrame: Difference between two groups of PDQ-39 measured at baseline (T0) and after 3 months (T1)
measure: Improvement of exercise tolerance capacity measured in the meters walked, by the 6-min walk test (6MWT)
timeFrame: Difference between two groups of 6MWT measured at baseline (T0) and after 3 months (T1)
measure: Improvement of balance measured by Balance Evaluation Systems Test (Mini BesTest)
timeFrame: Difference between two groups of Mini BesTest measured at baseline (T0) and after 3 months (T1)
Other outcomes:
Locations:
Study officials:
References:
citation: Schwab S, Vatankhah B, Kukla C, Hauchwitz M, Bogdahn U, Furst A, Audebert HJ, Horn M; TEMPiS Group. Long-term outcome after thrombolysis in telemedical stroke care. Neurology. 2007 Aug 28;69(9):898-903. doi: 10.1212/01.wnl.0000269671.08423.14.
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 2013 Apr 18.
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. doi: 10.1002/mds.870080326.
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. doi: 10.1258/135763306775321371.
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: 10.1002/mds.22498.
citation: 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 Neurosci. 2016;34(1):125-38. doi: 10.3233/RNN-150506.