NCT03346265

Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD

Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 55 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

In the present study, the investigators propose a rehabilitative program for Parkinson' disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. The rationale herein was that the RMP may globally improve patients in terms of trunk control, motor performance, muscle tone, endurance and so on, predisposing them to improvement of the gait rhythm and automaticity induced by use of the visual external cues. The primary aim of this pilot, randomized, controlled, trial with crossover was to establish whether a 8-week exercise program focused at improving gait in people with PD was more effective than a same-duration program of standard physiotherapy. The secondary aim was to evaluate the effect on the disease's severity. At this aims investigators used a quantitative 3D motion analysis system to evaluate gait parameters and UPDRS-II and UPDR-III and H-Y staging to evaluate the severity of the disease. The investigators hypothesised that the both exercise programs will improve standard physiotherapy, however the proposed program will yield better improvements for the people with PD.

Detailed description

This study is a pilot, bi-centric, exploratory, randomized, controlled, crossover design with blind observer . Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment. Both clinical (neurological visit and scale administration) and instrumental (gait analysis) assessments were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation). Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase. Participants were asked to maintain their pre-enrollment activity level and current medication dosage when not in the laboratory. Assessors, for both clinical and instrumental evaluations, were blinded to the allocation treatment. During the inactive condition, participants received usual care.

Conditions

• Parkinson Disease
• Movement Disorders

Interventions

Type	Name	Description
OTHER	Treatment A combined exercise program and gait training with sensory cues	Treatment A consisted in a combined exercise program of 40 min duration RMP
OTHER	Treatment B Conventional physiotherapy	Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code)

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2017-11-17
• Last updated: 2017-11-21

Locations

1 site across 1 country: Italy