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Completed

NCT Number: NCT03346265

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

55 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Italia Srl

Rome, Lazio, 00162, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment A combined exercise program and gait training with sensory cues

Other

Treatment A consisted in a combined exercise program of 40 min duration RMP

Treatment B Conventional physiotherapy

Other

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)

Primary outcomes

  1. Stance phase duration ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  2. swing phase duration ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  3. double support phase duration ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  4. cadence ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  5. step length normalized for the leg length ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  6. step length asymmetry ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  7. step width ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  8. mean speed ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  9. maximal arm displacement on the posterior-anterior axis ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

  10. trunk Range of motion ( change )

    Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

Secondary outcomes

  1. Unified Parkinson's Disease Rating Scale

    Time frame: 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)

    • Part I: evaluation of mentation, behavior, and mood
    • Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
    • Part III: clinician-scored monitored motor evaluation
    • Part IV: complications of therapy

  2. Hoehn and Yahr

    Time frame: 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)

    • Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement
    • Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test
    • Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent
    • Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted
    • Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2017
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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