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Serious game associated with Cycling for the treatment of Stroke patients

Serious Game associated with Cycle Ergometry for rehabilitation of hemiparetic patients due to Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5dt62k4
Enrollment
Unknown
Registered
2025-02-24
Start date
2023-07-01
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

Interventions

This is a quasi-experimental study of the time series type, involving 14 hemiparetic stroke patients, in the chronic phase of the disease (minimum 6 months post-stroke). The following will be evaluate
in Phase 2 (last 10 sessions), the participant performs 5 series of exercises, lasting 180 seconds each and with the game setting at 80% of the maximum speed obtained in the calibration before each se

Sponsors

Faculdade Guilherme Guimbala
Lead Sponsor
Faculdade Guilherme Guimbala
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Hemiparetic stroke patients volunteers; 18 years or older; clinically stable and in the chronic phase of the disease; able to walk independently, the use of a walking aid device was permitted; signing the Free and Informed Consent Form (FICF), expressing interest in participating in the project

Exclusion criteria

Exclusion criteria: Patients with hemiparesis resulting from pathologies other than stroke, as well as hemiplegic patients; patients who do not have lower limb impairment; patients who have bilateral motor impairment, which prevents characterization as hemiparetic; patients with severe visual and/or auditory impairment; uncooperative patients and/or with cognitive deficit (assessed with the Mini Mental State Examination); patients who are undergoing any other type of rehabilitation for the lower limbs or for the respiratory system

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: An improvement in respiratory function is expected, as verified by manovacuometry, based on the finding of a statistically significant difference (p<0.05) between pre- and post-intervention measurements;Found outcome 1: A significant difference was observed in the patients' respiratory function (p<0.05), with an increase in maximum inspiratory pressure (MIP) (p=0.012) and maximum expiratory pressure (MEP) (p=0.006), verified by manovacuometry, in the pre- and post-intervention periods

Secondary

MeasureTime frame
Expected outcome 2: An improvement in lower limb motor function is expected, as assessed by the Fugl-Meyer Assessment Scale, based on the finding of a statistically significant difference (p<0.05) between pre- and post-intervention measurements;Found Outcome 2: A significant difference was observed in lower limb motor function, as assessed by the Fugl-Meyer Assessment Scale, in the pre- and post-intervention periods, indicating that there was motor recovery (p=0.017);Expected outcome 3: An improvement in quadriceps femoris muscle strength on the paretic side is expected, as verified by dynamometry, based on the finding of a statistically significant difference (p<0.05) between pre- and post-intervention measurements;Found outcome 3: No significant difference was observed in quadriceps femoris muscle strength on either the paretic or non-paretic sides, as verified by dynamometry, in the pre- and post-intervention periods, indicating that there was no improvement in this variable on the paretic side (p=0.173) or on the non-paretic side (p=0.308);Expected outcome 4: An improvement in lower limb resistance, verified by the Sit-to-Stand Test, is expected, based on the finding of a statistically significant difference (p<0.05) between the pre- and post-intervention measurements;Found outcome 4: A significant difference was observed in lower limb resistance, verified by the Sit-to-Stand Test, in the pre- and post-intervention periods, indicating that there was an improvement in this variable (p=0.009);Expected outcome 5: An improvement in patients' functional mobility, verified by the Timed Up and Go Test, is expected, based on the finding of a statistically significant difference (p<0.05) between pre- and post-intervention measurements;Found outcome 5: A significant difference was observed in patients' functional mobility, verified by the Timed Up and Go Test, in the pre- and post-intervention periods, indicating that there was an improvement in this variable (p=0.002);Ex

Countries

Brazil

Contacts

Public ContactFernando Eichinger

Faculdade Guilherme Guimbala

fernando.eichinger@univille.br+55 (47) 3026-4000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)