Contracture
Conditions
Interventions
This is a phase I randomized clinical trial (feasibility study) with two parallel groups, with a sample size of 20 participants. There will be random allocation, with an allocation ratio of 1:1, alloc
E02.760.169.063.500.387
Sponsors
Universidade Federal de Minas Gerais
Hospital Risoleta Tolentino Neves
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals aged 18 years or older; clinical diagnosis of stroke (first episode); presence of lacunar infarction; be within the period of up to 10 days after stroke; unilateral clinical signs (hemiparesis with muscle weakness of the upper limb greater than or equal to 10%, confirmed by the average of three measurements of handgrip strength performed with a dynamometer); ability to respond to simple commands, such as “put your hand on your head” and “raise your arm” performed with the non-paretic limb; and who reside in the metropolitan region of Belo Horizonte.
Exclusion criteria
Exclusion criteria: Presence of orthopedic conditions in the upper limbs or others that prevent measurement proposed in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome: Passive joint range of motion (ROM) of shoulder lateral rotation, elbow extension, and wrist extension, measured by a digital inclinometer. All measurements will be performed bilaterally, with the participant in the supine position with the lower limbs in extension. The procedure for measuring each joint will be standardized. Contracture will be considered if there is a minimum loss greater than or equal to 10 degrees between the passive ROM measurements at baseline and the measurement at week 10 after the stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome 1: Recruitment feasibility will be assessed by calculating eligibility and recruitment rates. The recruitment rate will be defined in two ways: the number of subjects eligible for the feasibility study as a proportion of those screened and the number of subjects recruited for the feasibility study as a proportion of those eligible.;Outcome 2: Feasibility of the clinical measurements protocol will be defined through the distance covered by the therapist for data collection, time spent to apply the measurement instruments and proportion of measurements performed in a complete way.;Outcome 3: The feasibility of the intervention will be defined through adherence measures (adherence to the intervention protocol), number and duration of sessions, safety, in addition to cost. The task diary will record whether the participant completed the proposed exercise protocol in terms of dosage, intensity, and high frequency reported by each participant, in addition to reasons for not completing the exercise protocol throughout the study period. This information will be organized and analyzed to determine the number (%) of intervention sessions attended by each participant, the reasons for missing intervention sessions, the number of days the participant completed the entire proposed protocol, and the reasons for not completing the proposed protocol.;Outcome 4 - Muscle strength: Strength of the lateral and medial rotator muscles of the shoulder, flexors and extensors of the elbow and wrist will be measured through the Manual Muscle Test (MMT), where 0 means no strength and 5, normal strength. The scores obtained for the 6 muscle groups will be added (resulting in a score from 0 to 30). All measurements will be performed bilaterally, with the participant positioned in the supine position. The measurement will start with the non-paretic upper limb followed by the paretic one.;Outcome 5 - Spasticity: Spasticity of the medial and lateral rotator muscles of the shoulder, flexors | — |
Countries
Brazil
Contacts
Public ContactChristine Matozinho
Universidade Federal de Minas Gerais
Outcome results
None listed