Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD
Condition: Parkinson Disease; Movement Disorders
MeSH terms: Parkinson Disease; Movement Disorders
Study type: Interventional

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.
    

Intervention name(s): Treatment A combined exercise program and gait training with sensory cues; Treatment B Conventional physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Treatment A consisted in a combined exercise program of 40 min duration RMP; 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)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: progressive modular rebalancing; PMR; visual sensory cues; SC; Parkinson Disease; Movement Disorders; Parkinson rehabilitation; neurocognitive method; motor performance; improving gait; physiotherapy; 3D motion analysis system; improvements