Predictors of Gait Improvement in Patients With Parkinson's Disease After Rehabilitation

NCT03336307 | Completed

• 1 other identifier: s001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Parkinson's disease show a gait disturbance which is considered as one of the most disabling aspect of the disease that strongly impacts on patients' autonomy and quality of life. The mechanism underlying gait impairment is multi-factorial, reflects the global motor impairment of patients with PD and is mainly related to a neurotransmitter deficiency inducing bradykinesia, rigidity, abnormal trunk control and postural instability. For this reason, and considering the impact of social and economic costs, one of the main foci of intervention in patients with PD should be treating gait abnormalities. This need is further reinforced by the knowledge that gait outcomes are correlated with longevity, cognitive decline and adverse events. Besides the shorten-step gait clinical description of the gait disorder in PD, in the last years, studies using modern 3D motion analysis systems have further detailed the gait pattern in PD disclosing abnormalities in cadence, stance duration, swing duration, double support duration, leg length, step length, velocity, hip, knee and ankle ROMs. Such abnormal gait parameters seem to correlate with the clinical outcomes of UPDRS score, H-Y stage and milliequivalents of levodopa taken. Importantly, gait parameters can either normalize or improve after several rehabilitative treatment strategies including physiotherapy, assistive equipment, sensory cueing, treadmill training, physical activity, home base exercises. However, none of the previous studies specifically investigated which biomechanical factor can be modified after rehabilitation and which clinical characteristic can predict the rehabilitation-induced gait improvement. This would be extremely important to typifying, grouping and selecting patients, optimizing the rehabilitative strategies and cost management. The aims of the present study were to evaluate in a sample of patients with PD: i) which gait parameters can be modified after a short-term rehabilitation program; ii) which, if any, clinical variable can predict the improvement of the gait function after rehabilitation. At this aim we quantitatively evaluated the gait performance of PD patients by means of a 3-D motion analysis system.

Conditions

Parkinson Disease; Movement Disorders

Keywords

Parkinson disease; movement Disorders; gait disturbance; Parkinson; Parkinson gait; 3D motion analysis systems; motion analysis; Parkinson rehabilitation; rehabilitation gait improvement; gait improvement; SMART Capture; MATLAB software

Outcome Measures

Primary Outcomes (8)

• stance duration (change)

  time interval between two consecutive foot strikes of the same lower limb) expressed as a percentage of the stride duration

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• step length (change)

  the distance measured from the heel print of one foot to the heel print of the other foot

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• Step width (change)

  Step width variability discriminates gait of healthy young and older adults during treadmill locomotion.

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• walking speed (change)

  distance coverde by the body in unit of time

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• cadence (change)

  time of steps per unit time

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• The flexion-extension hips (change)

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• Trunk saggital plane (change)

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• Trunk frotal plane (change)

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

Secondary Outcomes (2)

• Unified Parkinson's Disease Rating Scale UPDRS Severity of parkinsonism

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

• Modified Hoehn and Yahr staging

  - T0 at baseline before rehabilitative treatment - T1 10- week after rehabilitative treatments

Study Arms (1)

Patients with Parkinson's disease

All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase. Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system. All patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease

Other: Rehabilitation program

Interventions

Rehabilitation program OTHER

all patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on: * endurance, strength, flexibility and balance with functional practice for all H/Y stage * endurance also for H/Y stage 1, * motor learning principles and cue functional for H/Y stage 2-3 * external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk).

Patients with Parkinson's disease

Eligibility Criteria

• Age: 48 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Fifty out of 67 patients with idiopathic PD assessed for eligibility were recruited at Rehabilitation Unit of Department of Medical and Surgical Sciences and Biotechnologies, University of Rome, Sapienza, and at Rehabilitation Unit of Policlinico Italia Centre, Rome, Italy. Patients were admitted for outpatient rehabilitation between May 2014 and April 2017. All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks. All participants could walk independently without walking devices. All patients were taking oral administrations of levodopa (18 patients), dopamine agonists (5 patients), or both (13 patients) and were recorded in on phase. Patients' clinical and anthropometric characteristics. Severity of parkinsonism was evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS-II and III) and the Hoehn and Yahr staging system.

You may qualify if:

• Diagnosis of idiopathic PD according to UK bank criteria
• Hoehn and Yahr stages 1 to 3.
• All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Italia Srl

Rome, Lazio, 00162, Italy

Location

Related Publications (5)

• Meunier S, Pol S, Houeto JL, Vidailhet M. Abnormal reciprocal inhibition between antagonist muscles in Parkinson's disease. Brain. 2000 May;123 ( Pt 5):1017-26. doi: 10.1093/brain/123.5.1017.

  PMID: 10775546 BACKGROUND

• Pistacchi M, Gioulis M, Sanson F, De Giovannini E, Filippi G, Rossetto F, Zambito Marsala S. Gait analysis and clinical correlations in early Parkinson's disease. Funct Neurol. 2017 Jan/Mar;32(1):28-34. doi: 10.11138/fneur/2017.32.1.028.

  PMID: 28380321 BACKGROUND

• Vieregge P, Stolze H, Klein C, Heberlein I. Gait quantitation in Parkinson's disease--locomotor disability and correlation to clinical rating scales. J Neural Transm (Vienna). 1997;104(2-3):237-48. doi: 10.1007/BF01273184.

  PMID: 9203085 BACKGROUND

• Pau M, Corona F, Pili R, Casula C, Sors F, Agostini T, Cossu G, Guicciardi M, Murgia M. Effects of Physical Rehabilitation Integrated with Rhythmic Auditory Stimulation on Spatio-Temporal and Kinematic Parameters of Gait in Parkinson's Disease. Front Neurol. 2016 Aug 11;7:126. doi: 10.3389/fneur.2016.00126. eCollection 2016.

  PMID: 27563296 BACKGROUND

• Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.

  PMID: 18946880 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Mobility Limitation

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Guido Caramanico, MD

  Università "La Sapienza di Roma"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 8, 2017
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)