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Effect of a multimodal physiotherapy intervention to target balance capacity in Huntington s disease a double blind randomized clinical trial

Effect of multimodal training with rhythmic cues in Huntington's Disease a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-463yhb3
Enrollment
Unknown
Registered
2022-08-01
Start date
2019-12-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's disease

Interventions

We will perform a prospective, double-blind, parallel group randomized clinical trial. Participants will sign an informed consent form before participation and a photo and video release as part of the
(2) history of balance and gait impairments collected by interview
(3) able to walk 10 minutes continuously and independently or with supervision indoors without walking aid. We will exclude participants who met the following exclusion criteria: (1) Mini Mental Statu
(2) instable medication over the past 3 months
(6) hearing or visual problems interfering with the tests or training. After the inclusion, no other physical therapy or physical activity modalities will be allowed during the period of the study. Pa

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of Huntington's Disease and confirmed by genetic test showing trinucleotide repeat number above 39; History of balance and gait impairments; and able to walk 10 minutes continuously and independently or with supervision indoors without walking aid

Exclusion criteria

Exclusion criteria: Mini-Mental Status Examination MMSE below 15 points; unstable medication over the past 3 months; and hearing or visual problems interfering with the tests or training

Design outcomes

Primary

MeasureTime frame
Assess balance as a primary outcome using the Mini-BESTest (Mini Balance Evaluation Systems Test) to analyze balance as a primary outcome. The Mini-BESTest is a 14-item balance test (total sum of 28 points), scored from 0 to 2 (higher score, better balance). We expect an improvement on balance in the post-intervention period. We will observe whether this improvement will be maintained after 6 months of follow-up by Mini-BESTest

Secondary

MeasureTime frame
Assess gait as a result of the Timed up and Go Test (TUG) to analyze gait speed as a secondary result. The TUG is a gait test that will be used to analyze gait speed. This test measures gait speed in seconds (time in seconds is the unit used) with a range of 5-60 seconds (which is the range). We expect an improvement on gait in post-intervention. We will observe whether this improvement will be maintained after 6 months of follow-up by TUG.;Assess balance as a secondary outcome using the Berg Balance Scale (BBS) to analyze balance as a secondary outcome. The BBS is a balance test and contains 14 items a total 56 of points, scored 0-4 points (higher score, better balance). We expect an improvement on balance in the post-intervention period. We will observe whether this improvement will be maintained after 6 months of follow-up by BBS.;Assess balance as a secondary outcome using the Retropulsion test to analyze balance as a secondary outcome. The retropulsion test is a balance test, which uses a score between 1-4 points, a lower score means better balance. We expect an improvement on balance in the post-intervention period. We will see if this improvement will be maintained after 6 months of follow-up by the Retropulsion test.;Assess motor clinical performance and functional capacity as a secondary outcome using the Unified Huntington's Disease Rating Scale to analyze motor clinical performance and functional capacity as a secondary outcome. The Unified Huntington's Disease Rating Scale contains 15 items that score 0-4 points (higher score worst motor performance). We expect an improvement on motor clinical performance and functional capacity in the post-intervention period. We expect an improvement on motor clinical performance and functional capacity will be maintained after 6 months of follow-up by the United Huntington's Disease Rating Scale. ;Assess adverse events and falls during the intervention period as a secondary outcome by a systematized weekly interview

Countries

Brazil

Contacts

Public ContactTamine Capato

Universidade de São Paulo

tamine.capato@hc.fm.usp.br+ 55 11 26620000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)