Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke

NCT02199093 | Completed DMC

• 1 other identifier: Upper_limb_apraxia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the effects of a mixed intervention of occupational therapy (rehabilitative and compensatory approach) at home to upper limb apraxia in mild and moderate patients post stroke in comparison to a control group with a traditional health educative protocol.

Conditions

Stroke; Apraxias

Keywords

MeSH terms:; Apraxias; Apraxia, Ideomotor; Stroke; Cerebral Stroke; Rehabilitation; Occupational therapy; Treatment Outcome; Activities of Daily Living

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Barthel index at 8 weeks

  This test can be recommended as an instrument of choice for measuring physical disability and is useful in assessing functional disability in basic activities of daily living, obtaining a quantitative estimate of the degree of dependence of the subject. It has good interobserver reliability with Kappa index between 0.47 and 1.00. According to intraobserver reliability, Kappa index between 0.84 and 0.97 was obtained.

  Eight weeks

• Change from Baseline in Barthel index at 16 weeks

  Sixteen weeks

Secondary Outcomes (14)

• Change from baseline in observation and scoring of ADL-Activities at 8 weeks

  Eight weeks

• Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks

  Eight weeks

• Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks

  Eight weeks

• Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks

  Eight weeks

• Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks

  Eight weeks

Study Arms (2)

Functional Rehabilitation of apraxia

EXPERIMENTAL

The participants will be randomly assigned to an experimental group, to receive intervention in upper limb apraxia at home since two approaches, a rehabilitative and another compensatory (providing adaptive strategies at home). The treatment will be performed three times a week, 30 minutes a day, during a 4-week period.

Other: Functional Rehabilitation of apraxia

Traditional health educative protocol

ACTIVE COMPARATOR

Control group will receive treatment with a traditional health educative protocol to improve his functionality in activities of daily living. The treatment will be performed twice in two month.

Other: Traditional health educative protocol

Interventions

Functional Rehabilitation of apraxia OTHER

The intervention will cover every type of approaches related with upper limb apraxia. We will use different kinds of tools to activate cerebral networks implied on apraxia, for facilitating the cerebral neuroplasticity in the recovering of the patient. On the other hand, when the function can not be improved, we will provide skills and strategies for enhance the environment adaptation and increasing the autonomy and independence.

Also known as: Intervention of occupational therapy in apraxia

Functional Rehabilitation of apraxia

Traditional health educative protocol OTHER

The traditional health educative protocol consist in an educational workshop for patients and caregivers where they are taught the implications of apraxia in their daily live, kind of errors of apraxia for gaining consciousness of the syndrome, and some strategies to facilitate the adaptation of the patient in her house.

Also known as: Traditional intervention in apraxia

Traditional health educative protocol

Eligibility Criteria

• Age: 25 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild-moderate stroke after two month of the cerebrovascular attack.
• Upper limb apraxia lasting at least 2 months.
• Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al., 2010.
• Voluntary participation.
• The neurologist, the occupational therapist and the patient judge the intervention to be necessary.

You may not qualify if:

• History of apraxia before current stroke.
• Stroke had occurred less than two months or more than twenty four month ago.
• Cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
• Severe aphasia.
• Previous brain tumour.
• History of other previous neurologic disorders.
• Mother tongue different to Spanish.
• Drugs addiction.
• Intellectual or learning disorders.
• Brain damage for traumatism or neurodegenerative process.
• A history of serious consciousness impairments
• Uncooperativeness, presence of orthopedic or other disabling disorders.

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital Clinico Universitario San Cecilio: collaborator

Study Sites (1)

University of Granada and University hospital "San Cecilio"

Granada, 18012, Spain

Location

Related Publications (2)

• Aguilar-Ferrandiz ME, Toledano-Moreno S, Garcia-Rios MC, Tapia-Haro RM, Barrero-Hernandez FJ, Casas-Barragan A, Perez-Marmol JM. Effectiveness of a Functional Rehabilitation Program for Upper Limb Apraxia in Poststroke Patients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):940-950. doi: 10.1016/j.apmr.2020.12.015. Epub 2021 Jan 22.

  PMID: 33485836 DERIVED

• Perez-Marmol JM, Garcia-Rios MC, Barrero-Hernandez FJ, Molina-Torres G, Brown T, Aguilar-Ferrandiz ME. Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial. Trials. 2015 Nov 5;16:508. doi: 10.1186/s13063-015-1034-1.

  PMID: 26542104 DERIVED

MeSH Terms

Conditions

Stroke; Apraxias; Apraxia, Ideomotor

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mª Encarnacion ME Aguilar, PdH

  Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Functional Rehabilitation of upper limb apraxia in patients Poststroke: Randomized Clinical Trial

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 24, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

ES (1)