Telemedicine Program in Parkinson's Disease (TELEPARK)

NCT02827812 | Unknown

• 1 other identifier: 1_neuro_veruno
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Improvement of quality of life (QoL) measured by the "Parkinson's disease questionnaire" (PDQ-39)

  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)

  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)

  Difference between two groups of Mini BesTest measured at baseline (T0) and after 3 months (T1)

Study Arms (2)

Participants Telemedicine Care (PTE)

EXPERIMENTAL

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; Other: Physical Intervention at home; Other: Home-Based telemedicine program

Participants Usual Care (PUC)

ACTIVE COMPARATOR

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; Other: Physical Intervention at home

Interventions

Comprehensive evaluation OTHER

At baseline (T0) and after 3-months (T1) all patients will be evaluated with Scales and questionnaire.

Participants Telemedicine Care (PTE); Participants Usual Care (PUC)

Physical Intervention at home OTHER

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.

Participants Telemedicine Care (PTE); Participants Usual Care (PUC)

Home-Based telemedicine program OTHER

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.

Participants Telemedicine Care (PTE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Related Publications (6)

• 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.

  PMID: 17724293 RESULT

• 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.

  PMID: 23599353 RESULT

• 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.

  PMID: 8341308 RESULT

• 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.

  PMID: 16438773 RESULT

• 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.

  PMID: 19353687 RESULT

• 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.

  PMID: 26684265 RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurological Rehabilitation Division

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 11, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share