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The influence of robot-assisted gait training on stroke survivors with ataxia

The influence of robot-assisted gait training on Stroke survivors with ataxia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8qhcys
Enrollment
Unknown
Registered
2017-07-05
Start date
2014-09-23
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

Stroke. Ataxia. Balance. Robot-Assisted Gait Training.

Interventions

All participants were examined at two time: before and after the protocol treatment was completed. The Berg Balance Scale (BBS), the Functional Independence Measure (FIM), the Timed Up and Go test (T
Device
Other
E02.779
G11.427.690
I01.409.418.750.600.480.461
C10.597.350.090

Sponsors

UNIFESP- Universidade Federal do Estado de São Paulo
Lead Sponsor
Associação de Assistência a Criança Deficiente
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Stroke survivors with ataxia. Minimum time of injury over 1 year. Clinical stability. Presence of hemiplegia or quadriplegia motor impairment. Both genders and who were at least 18 years of age were accepted and 80 years maximum. A physician examined all the patients and described their diagnosis in medical records.

Exclusion criteria

Exclusion criteria: Physical disability that made training with the robotic device unsafe such as cognitive impairment. Dementia. Aphasia. Presence of other orthopedic or neurosurgical problems in the lower extremities. Pressure ulcers on the hips or lower extremities. Weight higher than 120 kg. Ataxia originated by progressive disease.

Design outcomes

Primary

MeasureTime frame
At the end of the proposed protocol, individuals in both groups were expected to show improvement in balance, coordination, and overall functional independence when comparing the means of the functional scales used as an evaluation parameter: BERG, TUG, SARA and MIF. It was also expected that the group submited to robotic gait training assistance - TMAR would obtain better results when compared to the group that was only submitted to conventional gait training - TMRS. We assumed the following sample calculation with 5% of error, 95 % of level of confidence , number of elements in the universe of the research based on already described bibliographical references of 795,000 cases of stroke, these only 3% affecting posterior circulation . The sample calculus resulting in 45 individuals.;When compared the means of the BERG, TUG, SARA and MIF functional scales,it was observed that both groups obtained improvement in balance, coordination and functional independence in general activities. However, when comparative was done between groups: TMRS versus TMAR, no statistical difference was found to indicate that one of these interventions was superior to another. A total of 19 patients were enrolled in this study. All parametric results are illustrated as the mean ± standard deviation for each group in the tables and text. A level of significance of P < 0.05 was accepted for this study. The data were analyzed using change scores from pre- to post-training with intragroup and between-group comparisons. A Wilcoxon test was used for intragroup comparisons and a Mann-Whitney test for between-group comparison

Secondary

MeasureTime frame
Not expected secondary outcomes.

Countries

Brazil

Contacts

Public ContactMarcia Belas dos Santos

UNIFESP- Universidade Federal do Estado de São Paulo

marciabelas@yahoo.com.br*55(11)55764848

Outcome results

None listed

Source: REBEC (via WHO ICTRP)