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Effect of Robotic Therapy and Exercise Therapy on the Rehabilitation of the Arm of Hemiparetic People After Stroke in the Chronic Phase

Effect of Robotic Therapy and of Kinesiotherapy on the Rehabilitation of the Upper Limb of Hemiparetic Individuals After Stroke in the Chronic Phase

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2pcvt4
Enrollment
Unknown
Registered
2019-07-18
Start date
2017-12-27
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, Hemiplegia, Stroke Rehabilitation.

Interventions

The interventions will be in 2 groups of 16 volunteers each: Robotic Therapy Group and Kinesiotherapy Group. - Robotic Therapy Group: The device to be used will be the Assistive Rehabilitation Machine
Device
E02.760.169.063.500.387

Sponsors

Universidade Metodista de Piracicaba - Programa de Pós Graduação em Ciências do Movimento Humano
Lead Sponsor
Universidade Metodista de Piracicaba - Programa de Pós Graduação em Ciências do Movimento Humano
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years; single episode of ischemic vascular brain lesion for at least 6 months; upper limb motor impairment graded by the Fugl Meyer Scale, with a score of 7 for upper limb; degree of spasticity less or iqual 3 as measured by Modified Ashworth scale in the brachial biceps muscle; no range of motion limitation greater than 10 degrees of elbow extension and 10 degrees of extension of the wrist, assessed by goniometer; is not included or has participated in a robotic therapy program; have not received botulinum toxin or other types of anti-spastic drugs in the last three months.

Exclusion criteria

Exclusion criteria: Aphasias and agnosias that preclude the understanding of the virtual tasks proposed for the intervention; subluxation of the shoulder (anterior and / or inferior) evaluated clinically by palpation (bigger than 2 cm); presence of severe pain in the movement of the shoulder, elbow or wrist.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: decreased motor impairment of participants' upper limbs, assessed using the Fugl Meyer Scale, which provides a minimum score of 0 and a maximum score of 66 for the upper extremity, with a significance level of 5% for pre and post intervention.;Expected outcome 2: improvement of participants' compromised upper limb functionality assessed by the Modified Wolf Motor Function Test, composed of 17 tasks, which evaluates the execution speed of the task over time, quantifies the quality of the movement through a functional skill scale with a score of 1 to 5 and measures the grip strength in kgf through a dynamometer and shoulder flexion in kg on two specific tasks. With a level of significance of 5% in the pre and post intervention measurements.

Secondary

MeasureTime frame
Expected outcome 2: improvement of manual dexterity, assessed by means of the Box and Block Test, in which the participant transfers blocks of wood from one compartment to the other within a box with partition, in the time of 60 seconds. With a level of significance of 5% in the pre and post intervention measurements.;Expected outcome 3: increased range of motion of the shoulder, elbow, wrist and forearm, assessed by means of goniometry in degrees 0 to 180. With a significance level of 5% in pre and post intervention measurements.;Expected outcome 1: decreased spasticity, assessed using the Modified Ashworth scale with gradations from 0 to 4. With a significance level of 5% in pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactEli;Eli Pazzianotto Forti;Pazzianotto Forti

Universidade Metodista de Piracicaba - Programa de Pós Graduação em Ciências do Movimento Humano;Universidade Metodista de Piracicaba - Programa de Pós Graduação em Ciências do Movimento Humano

eli.forti@unimep.br;eli.forti@unimep.br+5501931241515;+5501931241515

Outcome results

None listed

Source: REBEC (via WHO ICTRP)