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Analysis of walking training with partial weight support for post stroke patients.

Multidisciplinary analysis of a motor rehabilitation protocol with partial weight support for post stroke patients: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7699xz
Enrollment
Unknown
Registered
2016-05-04
Start date
2014-02-03
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. Sequelae of stroke, not specified as haemorrhage or infarction.

Interventions

Control Group: 25 post stroke patients will receive 40 min of physical therapy usually offered to post stroke patients of the Ana Carolina Moura Xavier Rehabilitation Hospital (CHR), one to three time
Other
E02.779

Sponsors

Pontifícia Universidade Católica do Paraná
Lead Sponsor
Centro Hospitalar de Reabilitação Ana Carolina Moura Xavier
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The intended sample of 50 volunteers must satisy the following criteria: Confirmed stroke; lower limb residual hemiparesis; score 1 to 5 at Functional Ambulation Cathegory; age above 18 years old.

Exclusion criteria

Exclusion criteria: Present sequelae in both sides of the body or bilateral stroke; Diagnosed cardiac condition instable; present another neurological conditions (i.e. Alzheimer, Parkison, dementia, cerebelar disease, severe cerebelar disorders, etc); severe muscoloskeletal lower limb disorders not related to stroke and might interefere in gait; trunk circumference shorter than 36 cm or larger than 142 cm, body mass larger than 138 kg, height larger than 210 cm, due to the limitations of tue body weight support equipment.

Design outcomes

Primary

MeasureTime frame
EXPECTED PRIMARY OUTCOME: Increase on the average value of the Berg Balance Scale (BBS) in both groups, with larger change in the study group, verifyied applicating these scale (task performance and assignment of scores), observed by means of a change superior to 4.66 points (the minimal detectable change of the BBS).;OBSERVED PRIMARY OUTCOME: The observed outcome is in accordance to the expected one. The median of the BBS in the three evaluations of the control group were 30, 35 and 38 points while in the study group were 30, 45 and 46. The score of the BBS was above the minimal detectable change for all participants of the study group and for two participants od the control group.

Secondary

MeasureTime frame
EXPECTED SECUNDARY OUTCOMES Increase in the average stride velocity verifyied by means of three dimensional gait analysis test, observed by means of a change superior than 4.33 cm/s in the measurements before and after intervention. Increase in the average values of symmetries of the stance time, of the swing time and of the step length verifyied by means of three dimensional gait analysis test, observed by means of changes superior than 0.37, 1.08 and 1.61, respectivelly, in the measurements before and after intervention. Reduction of the average value of gait deviation index (GDI), verifyied by means of three dimensional gait analysis tests, observed by means of a change larger than 9.4 points for the paretic lower limb (PLL) and 7.5 for the non-paretic lower limb (NPLL), in the measurements before and after intervention. Reduction on the average value of the gait profile score (GPS), verifyied by means of three dimensional gait analysis tests, observed by means of a change larger than 2.5 degrees, in the measurements before and after intervention. Increase in the value of the Barthel index (functionality indicator) larger than 4.02 points (which is the minimal detectable change of this index), verfyied by the application of the Barthel index evaluation before and after the intervention. ;OBSERVED SECUNDARY OUTCOMES In general, the observed outcomes regarding gait variables were not in accordance to the expected ones. Specifically: In the control group, the median values gait velocity changed from 16.5 cm/s to 19.1 cm/s, while in the study group these values changed from 20.5 cm/s to 21.9 cm/s. In the control group, the median values of the symmetries of the stance time, of the swing time and of the step length changed from 0.89 to 0.91, from 2.13 to 1.8 e from 1.16 to 1.46, respectivelly. In the study group, the median values of the symmetries of the stance time, of the swing time and of the step length changed from 0.87 to 0.88, from 2.03 to 1.7

Countries

Brazil

Contacts

Public ContactElisangela Manffra

Pontifícia Universidade Católica do Paraná

elisangela.manffra@pucpr.br+55(41)32711674

Outcome results

None listed

Source: REBEC (via WHO ICTRP)