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Effects of association of an intensive motor training and brain stimulation on gait, balance and legs movement of people who suffered a stroke

Association of Lower Extremities - Constraint Induced Movement Therapy (LE-CIMT) and Transcranial Direct Current Stimulation (tDCS) on functionality and performance of lower limbs, gait and balance of post-stroke patients ¿ Triple-blinded, controled, randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-94bszgk
Enrollment
Unknown
Registered
2023-06-06
Start date
2023-07-03
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

Interventions

The 42 participants are going to be randomly allocated in two groups through sortition. Both groups will be submitted to 15 consecutive days of intervention, during 3.5 hours/day. Additionally they wi
E02.331.750

Sponsors

Associação de Assistência a Criança com Deficiência
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: Medical diagnosis of a single Stroke with more than six months of injury; both genders; minimum age of 18 years old and maximum age of 79; clinically stable; presenting hemiparesis as a sequel to the stroke; present a gait deficit caused by the sequelae of the stroke, classified at Level 3 to 5 of the Functional Ambulation Classification; go from sitting to standing independently even with the help of upper limbs; not having undergone orthopedic surgery in the last 6 months or chemical blockade in the last 3 months prior to the beginning of the study; no history of seizures; without anticonvulsant medication

Exclusion criteria

Exclusion criteria: Not tolerate the electrical stimulation; lesions in the scalp region where there will be electrode contact; to present convulsive episode during the protocol; epileptic Focus on Electroencephalogram exam even with no clinical manifestation; to have brain implant; to have cardiac markpacer; diagnosed or investigating bipolarity

Design outcomes

Primary

MeasureTime frame
Assess balance using the Mini-BESTest, which includes 14 items in 4 subscales (anticipatory/transitional postural control, reactive postural control, sensory orientation and gait stability). Each item is rated on a three-point ordinal scale with 0 being severe and 2 being normal, with a maximum score of 28 points. It is expected that the experimental group will have better results than the Control group, with a minimum difference of 3 points.

Secondary

MeasureTime frame
Assess the Gait Performance using 6 minutes Walk Test. It is expected that he experimental group will have better results than the Control group with a statistically meaningful change;Assess the Gait Speed using 10 meters Walk Test. It is expected that he experimental group will have better results than the Control group with a statistically meaningful change;Assess the Functional Mobility using Timed Up and Go Test. It is expected that he experimental group will have better results than the Control group with a statistically meaningful change;To evaluate the Real use of motor gains using the Lower Extremity - Motor Activity Log/Brasil. It is expected that he experimental group will have better results than the Control group with a statistically meaningful change;The Lower Extremities Strenght will be evaluated by 5X Sit to Stand Test. It is expected that he experimental group will have better results than the Control group with a statistically meaningful change

Countries

Brazil

Contacts

Public ContactElaine De Oliveira

Associação de Assistência a Criança com Deficiência

elaine_m_oliveira@yahoo.com.br+55(11) 5576-0816

Outcome results

None listed

Source: REBEC (via WHO ICTRP)