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Pilates Method in People With HAM/TSP

Primary Purpose

HAM/TSP, HTLV-1 Secondary Myelopathy, Balance

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates Method
task-oriented training protocol
Sponsored by
Pedreira, Érika, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HAM/TSP

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years.

Exclusion Criteria:

  • individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.

Sites / Locations

  • Universidade Católica do Salvador

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test-control group (TCG)

Control-test group (CTG)

Arm Description

The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. The TCG group will then conduct 20 task-oriented training sessions

The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises.

Outcomes

Primary Outcome Measures

Balance
Berg's Balance Scale (BBS)
Functional Mobility
Timed up and Go (TUG)
Gait Balance
Dynamic Gait Index (DGI)
Balance
Balance Evaluation Systems Test of dynamic balance (mini-BESTest)

Secondary Outcome Measures

Full Information

First Posted
May 23, 2018
Last Updated
April 1, 2021
Sponsor
Pedreira, Érika, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT04830319
Brief Title
Pilates Method in People With HAM/TSP
Official Title
Therapeutic Effect of the Pilates Method in People With HAM/TSP: a Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pedreira, Érika, M.D.

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
Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HAM/TSP, HTLV-1 Secondary Myelopathy, Balance, Gait Balance, Functional Mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test-control group (TCG)
Arm Type
Experimental
Arm Description
The test-control group (TCG) will initiate the protocol with exercises of the Pilates method, which includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. The TCG group will then conduct 20 task-oriented training sessions
Arm Title
Control-test group (CTG)
Arm Type
Active Comparator
Arm Description
The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises.
Intervention Type
Other
Intervention Name(s)
Pilates Method
Intervention Description
includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.
Intervention Type
Other
Intervention Name(s)
task-oriented training protocol
Intervention Description
The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises.
Primary Outcome Measure Information:
Title
Balance
Description
Berg's Balance Scale (BBS)
Time Frame
15 minutes
Title
Functional Mobility
Description
Timed up and Go (TUG)
Time Frame
3 minutes
Title
Gait Balance
Description
Dynamic Gait Index (DGI)
Time Frame
10 minutes
Title
Balance
Description
Balance Evaluation Systems Test of dynamic balance (mini-BESTest)
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years. Exclusion Criteria: individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.
Facility Information:
Facility Name
Universidade Católica do Salvador
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40000-00
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilates Method in People With HAM/TSP

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