Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

About this trial

The final goal of the present study is to propose a new approach in the Parkinson's Disease rehabilitation, focused on the use of robotic devices and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hoen and Yahr scale: 1-3 stage

FAC ≤ 2

Ranking scale score ≤ 3

Stability of drug treatment for at least 1 month

Disqualifiers

Concomitant participation in other studies

Lack of written informed consent

Clinical dementia rating (CDR) score ≥ 3

History of syncopal episodes, epilepsy and vertigo not controlled pharmacologically

Trial design

Design model

Parallel

Treatments tested in this trial

  • control arm

    Other intervention

    Each session will include 50 minutes of traditional physical rehabilitation therapy

  • virtual reality games

    Other intervention

    Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.

  • robotic treadmill

    Other intervention

    Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera

Treatment groups

195 Participants
are divided into 3 treatment groups
Group A: control armActive comparator 1 intervention
Group B: virtual reality games armExperimental treatment 1 intervention
Group C: robotic treadmill armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm

falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score \< 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk.

Time frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment

Secondary outcomes

1

difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm

gait performance will be assessed by walking speed through instrumental Gait Analysis

Time frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment
2

difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm

fear of falling will be evaluated by the Falls Efficacy Scale - International (FES-I). Higher scores represent greater the fear of falling (ranging from 16 to 64)

Time frame
before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment

Other outcomes

Sponsors and contacts

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