Telerehabilitation in People With Parkinson's Disease

ConditionParkinson's Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-80

SponsorIRCCS San Raffaele Roma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)
Device
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.
Conventional rehabilitation
Other intervention
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Experimental Group (EG)Experimental treatment 1 intervention

Group B: Control Group (CG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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 outcomes

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.

Time frame

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)

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).

Time frame

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)

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.

Time frame

Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

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.

Time frame

Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

Other outcomes

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.

Time frame

Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

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.

Time frame

Session 1 (Baseline, T0), Session 30 (End of treatment, approximately 10 weeks,T1)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele Roma

Lead sponsor

Ministry of Health, Italy

Collaborator

Source ClinicalTrials.gov

Apply now