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

Primary Purpose

Stroke, Acute, Parkinson Disease, Femur Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Novel locomotion treatment: curved-walking training
Standard locomotion treatment: straight-walking training
Standard physical therapy
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring gait rehabilitation, curved walking training, lower limb

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of LissoneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel treatment, curved-walking training

Usual care

Arm Description

It 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.

It 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.

Outcomes

Primary Outcome Measures

Change in 10 meter walk test (10MWT)
Time (seconds) needed by patients to walk for 10 meters

Secondary Outcome Measures

curved-walking test
Time (seconds) needed to complete the "S" curved trajectory (7.53 m)
Timed Up and Go (TUG)
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.
Curved Timed Up and Go
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 test
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.
Pain Numerical Rating Scale
Pain perceived on 11 levels (0-10)
Short Form Healthy Survey SF-36
Healthy status investigated in 36 questions
Falls Efficacy Scale (FES)
Risk of falls evaluated with 10 elements, each scored from 0 to 10. A total score higher than 70 suggests fear of falls.
Global Perceived Effect (GPE) for patients
Perceived effectiveness of training for patients. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Global Perceived Effect (GPE) for physiotherapists
Perceived effectiveness of training for physiotherapists. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Motricity Index (MI)
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
39-Item Parkinson's Disease Questionnaire (PDQ-39)
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)
Tampa Scale for Kinesiophobia (TSK)
Fear of movement - Parkinson's Disease only. Score ranges from 13 (no fear) to 52 (maximum fear).
Unified parkinson's Disease Rating Scale (UPDRS)
Parkinson's Disease prognosis information - Parkinson's Disease only. Score ranges from 0 (normal) to 199 (severe impairment).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Physical functionality, pain and stiffness - post-femoral fracture only. Its score ranges from 0 (high healthy status) to 100 (low healthy status)

Full Information

First Posted
April 24, 2018
Last Updated
October 11, 2021
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03545477
Brief Title
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
Official Title
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Parkinson Disease, Femur Fracture
Keywords
gait rehabilitation, curved walking training, lower limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel treatment, curved-walking training
Arm Type
Experimental
Arm Description
It 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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
It 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.
Intervention Type
Other
Intervention Name(s)
Novel locomotion treatment: curved-walking training
Intervention Description
Each training session is comprehensive of a 30-minute walking training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m)
Intervention Type
Other
Intervention Name(s)
Standard locomotion treatment: straight-walking training
Intervention Description
It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
It consists of 60 minutes of stretching, muscular conditioning and coordination,postural exercises for trunk control, standing, functional exercies and upper limb rehabilitation, customized on patient's need.
Primary Outcome Measure Information:
Title
Change in 10 meter walk test (10MWT)
Description
Time (seconds) needed by patients to walk for 10 meters
Time Frame
Baseline, 7 weeks, 20 weeks
Secondary Outcome Measure Information:
Title
curved-walking test
Description
Time (seconds) needed to complete the "S" curved trajectory (7.53 m)
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Curved Timed Up and Go
Description
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.
Time Frame
Baseline (test), day 2 (retest), 7 weeks, 20 weeks
Title
Balance test
Description
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.
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Pain Numerical Rating Scale
Description
Pain perceived on 11 levels (0-10)
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Short Form Healthy Survey SF-36
Description
Healthy status investigated in 36 questions
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Falls Efficacy Scale (FES)
Description
Risk of falls evaluated with 10 elements, each scored from 0 to 10. A total score higher than 70 suggests fear of falls.
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Global Perceived Effect (GPE) for patients
Description
Perceived effectiveness of training for patients. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Time Frame
7 weeks
Title
Global Perceived Effect (GPE) for physiotherapists
Description
Perceived effectiveness of training for physiotherapists. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.
Time Frame
7 weeks
Title
Motricity Index (MI)
Description
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
Time Frame
Baseline, 7 weeks, 20 weeks
Title
39-Item Parkinson's Disease Questionnaire (PDQ-39)
Description
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)
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Tampa Scale for Kinesiophobia (TSK)
Description
Fear of movement - Parkinson's Disease only. Score ranges from 13 (no fear) to 52 (maximum fear).
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Unified parkinson's Disease Rating Scale (UPDRS)
Description
Parkinson's Disease prognosis information - Parkinson's Disease only. Score ranges from 0 (normal) to 199 (severe impairment).
Time Frame
Baseline, 7 weeks, 20 weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Physical functionality, pain and stiffness - post-femoral fracture only. Its score ranges from 0 (high healthy status) to 100 (low healthy status)
Time Frame
Baseline, 7 weeks, 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio Ferriero
Phone
00390394657259
Email
giorgio.ferriero@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Ferriero, PhD
Organizational Affiliation
Istituti Clinici Scientifici Maugeri Spa, Scientific institute of Lissone
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone
City
Lissone
State/Province
Monza E Brianza
ZIP/Postal Code
20851
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Ferriero
Email
giorgio.ferriero@icsmaugeri.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
20022995
Citation
Tilson JK, Sullivan KJ, Cen SY, Rose DK, Koradia CH, Azen SP, Duncan PW; Locomotor Experience Applied Post Stroke (LEAPS) Investigative Team. Meaningful gait speed improvement during the first 60 days poststroke: minimal clinically important difference. Phys Ther. 2010 Feb;90(2):196-208. doi: 10.2522/ptj.20090079. Epub 2009 Dec 18.
Results Reference
background
PubMed Identifier
16328271
Citation
Courtine G, Papaxanthis C, Schieppati M. Coordinated modulation of locomotor muscle synergies constructs straight-ahead and curvilinear walking in humans. Exp Brain Res. 2006 Apr;170(3):320-35. doi: 10.1007/s00221-005-0215-7. Epub 2005 Nov 19.
Results Reference
background
PubMed Identifier
12859351
Citation
Courtine G, Schieppati M. Human walking along a curved path. I. Body trajectory, segment orientation and the effect of vision. Eur J Neurosci. 2003 Jul;18(1):177-90. doi: 10.1046/j.1460-9568.2003.02736.x.
Results Reference
background
PubMed Identifier
24903003
Citation
Godi M, Turcato AM, Schieppati M, Nardone A. Test-retest reliability of an insole plantar pressure system to assess gait along linear and curved trajectories. J Neuroeng Rehabil. 2014 Jun 5;11:95. doi: 10.1186/1743-0003-11-95.
Results Reference
background

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

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