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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545477
• Other study ID #: 2152CE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2021
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Giorgio Ferriero
• Phone: 00390394657259
• Email: giorgio.ferriero[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Parkinson Disease
• Stroke
• Stroke, Acute

Intervention

Other:
• Novel locomotion treatment: curved-walking training
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)
• Standard locomotion treatment: straight-walking training
It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation
• Standard physical therapy
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.

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri Spa, Scientific Institute of Lissone	Lissone	Monza E Brianza

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Epub 2005 Nov 19. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 meter walk test (10MWT)	Time (seconds) needed by patients to walk for 10 meters	Baseline, 7 weeks, 20 weeks
Secondary	curved-walking test	Time (seconds) needed to complete the "S" curved trajectory (7.53 m)	Baseline, 7 weeks, 20 weeks
Secondary	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.	Baseline, 7 weeks, 20 weeks
Secondary	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.	Baseline (test), day 2 (retest), 7 weeks, 20 weeks
Secondary	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.	Baseline, 7 weeks, 20 weeks
Secondary	Pain Numerical Rating Scale	Pain perceived on 11 levels (0-10)	Baseline, 7 weeks, 20 weeks
Secondary	Short Form Healthy Survey SF-36	Healthy status investigated in 36 questions	Baseline, 7 weeks, 20 weeks
Secondary	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.	Baseline, 7 weeks, 20 weeks
Secondary	Global Perceived Effect (GPE) for patients	Perceived effectiveness of training for patients. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.	7 weeks
Secondary	Global Perceived Effect (GPE) for physiotherapists	Perceived effectiveness of training for physiotherapists. A score from 1 (significantly improved) to 7 (significantly worsened) is assigned.	7 weeks
Secondary	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	Baseline, 7 weeks, 20 weeks
Secondary	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)	Baseline, 7 weeks, 20 weeks
Secondary	Tampa Scale for Kinesiophobia (TSK)	Fear of movement - Parkinson's Disease only. Score ranges from 13 (no fear) to 52 (maximum fear).	Baseline, 7 weeks, 20 weeks
Secondary	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).	Baseline, 7 weeks, 20 weeks
Secondary	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)	Baseline, 7 weeks, 20 weeks