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Effects of robotic therapy on the gait of post-stroke individuals

Effects of robotic therapy on the gait kinematics of chronic hemiparetic individuals: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3ft2rq
Enrollment
Unknown
Registered
2018-06-25
Start date
2018-06-30
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

Central nervous system disorders Stroke Paresis

Interventions

30 subjects will be allocated to two groups that correspond to 2 treatment conditions
The first condition will be called TR (robotic therapy) which will comprise 6 weeks of robotic therapy. The second condition will be 6 weeks of passive contact with the robotic device. The patients wi
Device
Other

Sponsors

Universidade de São Paulo
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: The subjects who present the last episode of stroke, single, unilateral and ischemic for more than 6 months, without documented changes in motor or sensory impairment, will be included in the study; muscle tone or reflex activity in the 3 months prior to the subject's participation in the study; the level of spasticity equal to or less than 2 in the Modified Ashworth Scale for lower limbs, allowing individuals to perform the test, 3 to 5 according to the Functional Ambulation Category. The ankle joint should be kept in a neutral position and without deformities. In addition, they must present a minimum score in the Mental State Mini Exam according to the volunteer's schooling. The Beck Depression Scale inventory will be used to identify individuals with depression. Individuals with values greater than 63 will be excluded. The age range will be between 40 and 70 years.

Exclusion criteria

Exclusion criteria: Subjects with severe cardiovascular diseases, heart failure, arrhythmias or angina pectoris, will be excluded from the study; rheumatic diseases; body mass index greater than 28 kg/m² changing the reliability of the EMG data; other orthopedic or neurological diseases that compromise the collection of data through the isokinetic test and cognitive or communication deficiencies that make it impossible to perform the procedures; painful contractures or deformities in the paretic ankle; shortenings that make it impossible to perform tests or promote pain; show the range of motion less than 10o for dorsiflexion and 20o for plantar flexion according to goniometry; cerebellar ataxia; sensory deficit defined by the loss of proprioception of the first phalangeal metatarsus; hemi- sensorial neglect on neurological examination; various neurological disorders; participation in rehabilitation programs; the presence of pain during the procedures will be considered exclusion criterion.

Design outcomes

Primary

MeasureTime frame
This project aims To present the effect of the 6-week robotic therapy protocol on the functional performance of chronic hemiparetic individuals evaluated by means of functional scales (TUG test, Berg balance scale, Fughl-Meyer scale and kinematic analysis with cameras).;To describe the effect of the Anklebot® robotic therapy protocol on ankle motor control during the steadiness test (torque-Nm) using the Biodex equipment;o describe the effect of robotic therapy on the following electromyographic variables: peak of activation and median frequency of the anterior tibial, medial gastrocnemius, vastus medial, femoral biceps during assessments, baseline after first week and after second week of treatment

Secondary

MeasureTime frame
(Game / test) tool similar to the Biodex dynamometer test to evaluate the motor control of the ankle of patients with motor deficits that allow investigating the effect of robotic therapy on the submaximal torque of these individuals, accuracy, and accuracy using the equipment itself will be used in robotic therapy, Anklebot.

Countries

Brazil

Contacts

Public ContactMarcela Silva Couto

Universidade de São Paulo

marcela.deabreu5@gmail.com+55-16-991932926

Outcome results

None listed

Source: REBEC (via WHO ICTRP)