Pilates Method in People With HAM/TSP

Not Applicable

Completed

• Conditions: Balance; HTLV-1 Secondary Myelopathy; Functional Mobility; HAM/TSP; Gait Balance

• Registration Number: NCT04830319
• Lead Sponsor: Pedreira, Érika, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-20
• Study First Submitted: 2018-05-23
• Primary Completion: 2018-08-20
• Study Completion: 2020-03-15
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Study First Posted: 2021-04-05
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Functional Mobility	3 minutes	Timed up and Go (TUG)
Balance	20 minutes	Balance Evaluation Systems Test of dynamic balance (mini-BESTest)
Gait Balance	10 minutes	Dynamic Gait Index (DGI)

Trial Locations

Locations (1)

Universidade Católica do Salvador; 🇧🇷 Salvador, Bahia, Brazil