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Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations

Not Applicable
Conditions
Parkinson Disease
Femur Fracture
Stroke, Acute
Interventions
Other: Standard physical therapy
Registration Number
NCT03545477
Lead Sponsor
Istituti Clinici Scientifici Maugeri SpA
Brief Summary

The recovery of walking ability is crucial to promote independence in daily living and is one of the major goal of neuromotor rehabilitation.

Currently, standard rehabilitative programs are usually based on straight-walking training (SWT) and the assessment of their effects is performed through functional scales based on straight-walking trajectories, e.g. Timed Up and Go (TUG), 10 meters walking test (10mWT).

Curved-walking training (CWT) may be interesting to provide an ecological and challenging context during rehabilitation. Indeed, CWT is based on demanding neural processes that drive an asymmetrical contribution at lower limb level, challenging balance ability and complex adaptation such as body weight shifting in response to centrifugal force and production of different step lengths.

Up to now, literature has investigated CWT in healthy adults in terms of muscular activation, kinematics and kinetics of the movement. Results showed that CWT needs a different biomechanical strategy with respect to SWT. Nevertheless CWT has not been investigated in pathological adults.

The present study aims at assessing the effectiveness of a rehabilitative physical therapy based on CWT with respect to traditional SWT for the recovery of locomotor abilities in neurological and orthopaedic patients.

The hypothesis is that a training based on curved-walking is ecologically meaningful and may be superior with respect to standard training in improving balance, walking abilities, and independence in activity of daily live of patients.

A secondary aim of the project is to propose an innovative functional scale based on the timed up and go on curved trajectory (CTUG), and to determine its reliability and responsiveness, establishing the minimum Detectable Change (MDC) and the Minimal Clinically Important Difference (MCID).

A single-blind randomized controlled study is being carried out on three different populations:

* Post-acute stroke patients

* Idiopathic Parkinson Disease

* Femoral fracture

A healthy group is also being recruited to provide reference values of CTUG. For each of the three populations, subjects are randomized into two groups. The experimental one performs a novel rehabilitative program composed by a 30-minute training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m) in addition to usual care. The control group performs an equal dose of traditional treatment on straight trajectories.

Both groups undergo 20 90-minutes sessions of training (three times a week for seven weeks).

Participants are evaluated at baseline (T0), after training (T1), and at a three-months follow-up visit (T2).

The primary outcome measure is the 10mWT (minimal clinically important difference of 0.16 m/s identified by Tilson and colleagues). On the basis of this measure, a sample size of 70 subjects for each population was computed.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
210
Inclusion Criteria
  • Post-acute stroke patients experiencing a stroke less than 6 months before recruitment
  • Idiopathic Parkinson Disease with disability level from moderate to severe (modified Hoehn & Yahr scale 2.5-4)
  • Femoral fracture, less than 1 month form surgery
Exclusion Criteria
  • Cognitive deficits (Mini Mental Scale Evaluation < 24)
  • Hemineglect
  • Modified Ashworth Scale of lower limb >2
  • Unstable pharmacological treatment for Parkinson's Disease during the 15 days before the recruitment
  • cardiopathic conditions
  • metabolic conditions (e.g. dialysis) that prevent patients from aerobic training
  • Previous history of major neurological, vascular, musculoskeletal disorders
  • Body Mass Index > 30 Kg/m2
  • Invasive pharmacological treatment or surgery for Parkinson's disease
  • lower limb pain (VAS >3)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Novel treatment, curved-walking trainingStandard physical therapyIt consists of 20 sessions of training (three times a week for seven weeks) composed by standard physical therapy and a novel approach to locomotion rehabilitation based on curved-walking training. Each session lasts about 90 minutes.
Usual careStandard physical therapyIt consists of 20 sessions of training (three times a week for seven weeks) of standard physical therapy and conventional straight-walking training. Each session lasts about 90 minutes.
Primary Outcome Measures
NameTimeMethod
Change in 10 meter walk test (10MWT)Baseline, 7 weeks, 20 weeks

Time (seconds) needed by patients to walk for 10 meters

Secondary Outcome Measures
NameTimeMethod
Timed Up and Go (TUG)Baseline, 7 weeks, 20 weeks

Time (seconds) needed to the patient to stand up upon therapist's command, walk 3 meters, turn around, walk back to the chair and sit down.

Global Perceived Effect (GPE) for patients7 weeks

Perceived effectiveness of training for patients. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.

39-Item Parkinson's Disease Questionnaire (PDQ-39)Baseline, 7 weeks, 20 weeks

Quality of life questionnaire - Parkinson's Disease only. The questionnaire is based on 39 questions and the total score ranges from 0% (no difficulty) to 100% (maximum level of difficulty)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Baseline, 7 weeks, 20 weeks

Physical functionality, pain and stiffness - post-femoral fracture only. Its score ranges from 0 (high healthy status) to 100 (low healthy status)

curved-walking testBaseline, 7 weeks, 20 weeks

Time (seconds) needed to complete the "S" curved trajectory (7.53 m)

Pain Numerical Rating ScaleBaseline, 7 weeks, 20 weeks

Pain perceived on 11 levels (0-10)

Short Form Healthy Survey SF-36Baseline, 7 weeks, 20 weeks

Healthy status investigated in 36 questions

Global Perceived Effect (GPE) for physiotherapists7 weeks

Perceived effectiveness of training for physiotherapists. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.

Motricity Index (MI)Baseline, 7 weeks, 20 weeks

Functional ability of limb - post-stroke population only. The quality of different limb movement are scored from 0 to 33 points, with a total score of 100 for each limb

Tampa Scale for Kinesiophobia (TSK)Baseline, 7 weeks, 20 weeks

Fear of movement - Parkinson's Disease only. Score ranges from 13 (no fear) to 52 (maximum fear).

Curved Timed Up and GoBaseline (test), day 2 (retest), 7 weeks, 20 weeks

Time (seconds) needed to the patient to stand up upon therapist's command, walk 3 meters following the curved trajectory, turn around, walk back on the curved trajectory to the chair and sit down.

Balance testBaseline, 7 weeks, 20 weeks

Balance performance assessed by Balance test. Postural stability is evaluated using the commercial balance board Balance Master basicTM, NeuroCom® International, Inc. Assessments evaluate the postural sways during upright stance both with eyes open and closed; the limits of stability in different directions (forward, backward, right, and left); and the capability to shift the weight both left/right and forward/backward.

Falls Efficacy Scale (FES)Baseline, 7 weeks, 20 weeks

Risk of falls evaluated with 10 elements, each scored from 0 to 10. A total score higher than 70 suggests fear of falls.

Unified parkinson's Disease Rating Scale (UPDRS)Baseline, 7 weeks, 20 weeks

Parkinson's Disease prognosis information - Parkinson's Disease only. Score ranges from 0 (normal) to 199 (severe impairment).

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone

🇮🇹

Lissone, Monza E Brianza, Italy

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