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The effect of Neuromodulation and Restriction Therapy on the upper limb of people after stroke

Effects of transcranial Direct Current Stimulation and modified Constraint Therapy on upper limb motor function in people after chronic Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-55p8vr4
Enrollment
Unknown
Registered
2023-10-27
Start date
2023-11-10
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

Paresis

Interventions

This is a randomized, sham-controlled, double-blind clinical trial, made up of 24 volunteer participants. Experimental group: 12 people aged between 40 and 70 with motor sequelae in the upper limb fol
E02.331.750

Sponsors

Universidade Federal da Paraíba
Lead Sponsor
Universidade Federal da Paraíba
Collaborator

Eligibility

Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Single episode of stroke, ischemic or hemorrhagic, with at least six months between the ictus and their inclusion in the study, proven by a medical report; aged between 40 and 70 years; classified with a degree of spasticity with a score less than or equal to 2, detected using the Modified Ashworth Scale for spasticity; active extension capacity of 10 degrees in the metacarpophalangeal and interphalangeal joints, and 10 degrees in the wrist joint; no cognitive deficit (score less than 24), verified using the Mini-Mental State Examination; pain threshold with a maximum score of 4 in the affected upper limb, verified using the Visual Analog Pain Scale

Exclusion criteria

Exclusion criteria: Those who had clinical evidence of multiple brain injuries and other comorbidities, inability to ambulate and instability to walk with the healthy upper limb (HUL) immobilized, failure to perform the training tasks with the paretic HUL, or symptoms of depression or severe anxiety, as verified by the Hospital Anxiety and Depression Scale, would be excluded from the study.

Design outcomes

Primary

MeasureTime frame
We expected to find an increase in upper limb motor function using the Fugl-Meyer Assessment Scale, applied only to the upper limb section, of at least 5% in the pre-and post-intervention measurements, and after 4 weeks.

Secondary

MeasureTime frame
Greater use of the upper limb most affected after the stroke in activities of daily living is expected from the Motor Activity Log Scale (MAL). The higher the average obtained on the scales, the better the quality and quantity of use of the most affected upper limb in performing ADLs, based on an increase of at least 5 points in the measurements before, after, and 4 weeks after the intervention.;We expect to see an improvement in the functional recovery of the upper limb using the Jebsen-Taylor Test, which measures the time needed to perform seven functional activities, based on a decrease of at least 5% in the pre-and post-intervention measurements. ;We expect to see an improvement in handgrip strength using a hydraulic hand dynamometer, based on a variation of at least 5% in the pre-and post-intervention measurements. ;We expect to see an increase in fine motor coordination using the 9 pins and holes test, based on a variation of at least 5% of the time in the pre-and post-intervention. ;We expected to see an increase in gross motor coordination using the Box and Blocks Test, based on a variation of at least 5% of the time in the pre-and post-intervention.

Countries

Brazil

Contacts

Public ContactMaria Luísa Gomes

Universidade Federal da Paraíba

mlag@academico.ufpb.br+55833216-7183

Outcome results

None listed

Source: REBEC (via WHO ICTRP)