Gait Re-education Program in Subjects With Parkinson´s Disease

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Recruiting
CT.gov ID
NCT05131880
Collaborator
(none)
40
1
2
10
4

Study Details

Study Description

Brief Summary

Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment status.

Condition or Disease Intervention/Treatment Phase
  • Other: GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
N/A

Detailed Description

All participants interested in participating in the present study will be part of the research project. Once recruited, they will be randomly assigned to two intervention groups: A and B. Group A (control group) will perform a conventional physiotherapy treatment 2/3 sessions per week of 30 minutes duration; on the other hand, group B (intervention group) will perform the treatment of group A and a therapeutic supplement of 2-3 sessions per week of about 30 minutes. During the research period, several measurements of the variables studied will be taken: one before the intervention, one immediately after the end of the intervention, and another measurement 12 weeks after the end of the intervention.

The treatment will be carried out and supervised at all times by qualified physiotherapists, who will explain to you what the treatment consists of, the days you should attend, and the schedules. No adverse effects are expected from this therapy that could pose a risk for health.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Gait Re-education Program on a Sequential Square Treadmill (Tapiz Fisior) in Subjects With Parkison´s Disease
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

The experimental group will participate in a physiotherapy program with the addition of the Fisior Tapestry Method physiotherapy program, three sessions per week, for 12 weeks. An initial assessment will be made at the beginning of the study, another one at the end of the intervention, and another one at follow-up.

Other: GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment condition.

Active Comparator: Control

The control group will participate in a physiotherapy program three sessions per week for 12 weeks.

Other: GAIT RE-EDUCATION PROGRAM ON A SEQUENTIAL MAT IN SUBJECTS WITH PARKINSON'S DISEASE
Randomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment condition.

Outcome Measures

Primary Outcome Measures

  1. Balance and Walk [15 min]

    Short Physical Performance Battery test

  2. Fall Risk on elderly [15 min]

    Timed Up and Go test

  3. Fall Risk [10 min]

    Fall Skip

  4. Functionality and independence [20 min]

    Barthel Index

Secondary Outcome Measures

  1. General Satisfaction [10 min]

    General satisfaction test

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Older than 50 years.

  • Diagnosed Parkinson Disease.

  • Not to be institutionalized.

  • Barthel index scores of ≥ 60.

  • Ability to communicate and to get up and walk at least 10 m (33 ft)

Exclusion Criteria:
  • Medical criteria for contraindication of treatment.

  • Severe behavioral problems that hinder participation in the training program.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alberto Bermejo Franco Villaviciosa de Odón Madrid Spain 28670

Sponsors and Collaborators

  • Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alberto Bermejo Franco, Alberto Bermejo Franco, Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
NCT05131880
Other Study ID Numbers:
  • CIPI/21/032
First Posted:
Nov 23, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021