Clinical trial NCT03346265: Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD
Official title: Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Movement Disorders
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
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 47
Sex: ALL
Minimum age (years): 55
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic PD according to UK bank criteria
* Hoehn and Yahr stages 1 to 3.
* United Parkinson Disease Rating Scale (UPDRS) gait subscore of 1 or more, no change in medication during the study period.
* All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks.

Exclusion Criteria:

* cognitive deficits (defined as scores of \<26 on the Mini-Mental State Examination \[MMSE\]),
* moderate or severe depression (defined as scores of \>17 on the Beck Depression Inventory \[BDI\]),
* orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.

Primary outcomes:
measure: Stance phase duration ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: swing phase duration ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: double support phase duration ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: cadence ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: step length normalized for the leg length ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: step length asymmetry ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: step width ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: mean speed ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: maximal arm displacement on the posterior-anterior axis ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
measure: trunk Range of motion ( change )
timeFrame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: 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)
measure: Hoehn and Yahr
timeFrame: 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)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Italia Srl
state: Lazio
Study officials:
affiliation: Università "La Sapienza di Roma"
name: Mariano Serrao, PHD
role: PRINCIPAL_INVESTIGATOR
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