Telerehabilitation in People With Parkinson's Disease

Parkinson's Disease Clinical Trial

— TEMPO  

Official title:

Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773885
• Other study ID #: RP 21/30
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: IRCCS San Raffaele Roma
• Contact: Michela Goffredo, PhD.
• Phone: +390652252319
• Email: michela.goffredo[@]sanraffaele.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed. The study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.

Description:

The scientific literature has shown that appropriate exercise can decrease some non-motor symptoms of PD such as fatigue, depression, apathy, and cognitive impairment, and it can positively affect motor performance. However, access to rehabilitation centers is often difficult, with logistic and economic barriers for those not living near a specialized hospital. In recent years, the use of technologies has considerably progressed, and, with the development of telemedicine systems, remote treatments have become a viable option for the management of patients with PD. The TR has the potential to optimize the timing, intensity, and personalization of rehabilitation intervention and offers the opportunity for a flexible implementation of treatment protocols and the ability to monitor patient progress in real-time. In particular, for patients with neurological degenerative pathologies, who need periodical and tailored rehabilitation for the whole life, the TR has proved feasible and effective. The recent systematic review by Vellata found that the literature on TR in people with PD is limited. The published studies on TR for PD showed that it is feasible and effective in maintaining and/or improving some clinical and non-clinical aspects of PD such as: balance and walking, speech and voice, quality of life, patient satisfaction. However, although TR is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's disease. In this context, the efficacy of TR in the management of motor and non-motor symptoms of PD has to be further investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 30 and 80 years;
• diagnosis of Parkinson's Disease according to the "Movement Disorders Society's diagnostic criteria";
• Hoehn & Yahr (H&Y) score between 2 and 3 (ON-state);
• absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 = 2;
• absence of cognitive impairment measured by the MoCA total score = 18;
• stabilized drug treatment;
• have access to the Internet for TR;
• have a caregiver available during rehabilitation sessions in TR;
• have sufficient cognitive and linguistic level to understand and comply with study procedures;
• sign informed consent.

Exclusion Criteria:

• having any cognitive problems or low compliance that prevent using the TR system;
• other neurological pathologies, psychiatric complications or personality disorders;
• musculoskeletal diseases that impair movement;
• presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 > 2;
• presence of cognitive impairment measured by the MoCA total score < 18;
• severe cognitive or linguistic deficits (inability to understand and comply with study procedures);
• presence of blurred or low vision problems;
• hearing and speech impairment affecting participation in the system;
• absence of signature of the informed consent.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)
The patients will carry out motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy). The motor exercises will be performed using inertial sensors for the acquisition and processing of the movement performed by the patient. This data is shown to the patient with visual and auditory feedback in a serious games environment. The exercises will cover the rehabilitation of balance and lower limbs, for example Balance on one leg, March in place, Stand on tiptoe, Squat, etc. The physiotherapists involved in the study will define a protocol of exercises in TR mode customized according to the characteristics and needs of the patient. The exercises in the speech therapy and cognitive domains will be defined by the specialized staff based on the characteristics of the patient. The duration of the rehabilitation treatments is 9 hours per week.

Other:
• Conventional rehabilitation
The patients will carry out conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices. The motor exercises will concern the rehabilitation of balance, trunk, and lower limbs and will be performed with a physiotherapist who will customize the treatment based on the characteristics and needs of the patient. The occupational therapy, speech therapy, psychotherapy treatments will be defined by the specialized staff based on the characteristics of the patient. The duration of the rehabilitation treatments is 9 hours per week.

Locations

Country	Name	City	State
Italy	San Raffaele Cassino	Cassino	Frosinone
Italy	IRCCS San Raffaele Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Barbour PJ, Arroyo J, High S, Fichera LB, Staska-Pier MM, McMahon MK. Telehealth for patients with Parkinson's disease: delivering efficient and sustainable long-term care. Hosp Pract (1995). 2016;44(2):92-7. doi: 10.1080/21548331.2016.1166922. — View Citation

Cikajlo I, Hukic A, Dolinsek I, Zajc D, Vesel M, Krizmanic T, Blazica B, Biasizzo A, Novak F, Peterlin Potisk K. Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Int J Rehabil Res. 2018 Sep;41(3):230-238. doi: 10.1097/MRR.0000000000000291. — View Citation

Linares-Del Rey M, Vela-Desojo L, Cano-de la Cuerda R. Mobile phone applications in Parkinson's disease: A systematic review. Neurologia (Engl Ed). 2019 Jan-Feb;34(1):38-54. doi: 10.1016/j.nrl.2017.03.006. Epub 2017 May 23. English, Spanish. — View Citation

Magrinelli F, Picelli A, Tocco P, Federico A, Roncari L, Smania N, Zanette G, Tamburin S. Pathophysiology of Motor Dysfunction in Parkinson's Disease as the Rationale for Drug Treatment and Rehabilitation. Parkinsons Dis. 2016;2016:9832839. doi: 10.1155/2016/9832839. Epub 2016 Jun 6. — View Citation

Vellata C, Belli S, Balsamo F, Giordano A, Colombo R, Maggioni G. Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Front Neurol. 2021 Aug 26;12:627999. doi: 10.3389/fneur.2021.627999. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait analysis (GAIT)	In a subgroup of subjects. Optical tracking system with reflective markers and force plates for measuring (according to a model used in gait analysis) spatio-temporal parameters, joints kinematics and kinetics (joint moments and foot-soil reaction forces) during a 10-meter-long path.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Other	Posturograghy (POSTURE)	In a subgroup of subjects. Force plate posturography measurements: centre of pressure displacement and velocity parameters. Data will be collected under 2 different conditions: normal standing with eyes open, normal standing with eyes closed. Postural sway will be measured in the anteroposterior and mediolateral directions.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Primary	Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - part II	MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assessed motor experiences of daily living (Range 0-52). A higher score indicated more severe symptoms of PD.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Secondary	Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part I assessed non-motor experiences of daily living and has 2 components (Range 0-52). Part IA contained 6 questions and were assessed by the examiner (Range 0-24). Part IB contained 7 questions on non-motor experiences of daily living which were completed by the participant (Range 0-28). Part II assessed motor experiences of daily living (Range 0-52). It contained 13 questions completed by the participant. Part III assessed the motor signs of PD and was administered by the rater (Range 0-132). Part III contained 33 scores based on 18 items. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III (Range 0-236). A higher score indicated more severe symptoms of PD.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Secondary	Change in the Parkinson's Disease Questionnaire-8 (PDQ-8)	The Parkinson's Disease Questionaire-8 is a short-form version, derived from the Parkinson's Disease Questionaire-39. It is a self-administered questionnaire, used to measure the quality of life in People with PD. It consists of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Secondary	Change in the Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the Lee Silverman Voice Treatment LOUD assessment (LSVT/LOUD)	Maximum duration of sustained vocal phonation and variation of maximum fundamental frequency according to the LSVT/LOUD assessment protocol.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the Timed Up and Go test (TUG)	The TUG test assesses mobility, balance, walking ability, and fall risk in older adults. It is a measure of function with correlates to balance and fall risk. The participant is asked to get up from the chair she/he is sitting in, walk the marked distance of 3 meters and return to her/his seat again. The elapsed time is recorded in seconds.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the Timed Up and Go Dual task test (TUG-D)	The TUG-D test is a dual-task dynamic measure for identifying individuals who are at risk for falls. It evaluates balance with a simultaneous cognitive and motor task. The cognitive task of the test is serial triple subtraction while the TUG test is a motor task. Balance performance will be recorded in seconds.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the mini-Balance Evaluation Systems Test (mini-BESTest)	The mini-BESTest is a shortened version of the Balance Evaluation Systems Test. It aims to target and identify 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits. The test was shortened based on factor analysis to include dynamic balance only and to improve clinical utilization. It is 36 items scale that evaluates Balance with total score of 28.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the 10-meter WalkTest (10mWT)	The 10mWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)
Secondary	Change in the New Freezing of Gait Questionnaire (NFOG-Q)	The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reported questionnaire consisting of 9 items that measure freezing of gait (FOG). The NFOG-Q is the renewed version of the FOG-Q, which originally consisted of 6 items. The total score ranges from 0 to 24, and higher scores denote more severe FOG.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)
Secondary	Change in the Activities-specific Balance Confidence scale (ABC)	Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing activities. The items are scored on a 0-100% scale. Items are totalled and then averaged. The higher the average score the higher the confidence with balance and the less likely risk there is for falling.	Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1) and a follow-up (2 months after the end of the treatment, T2)