Clinical trial NCT02199093: Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke
Official title: Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Apraxias
Keywords: MeSH terms:
Apraxias
Apraxia, Ideomotor
Stroke
Cerebral Stroke
Rehabilitation
Occupational therapy
Treatment Outcome
Activities of Daily Living
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Clinico Universitario San Cecilio
First posted: 2014-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Apraxia is a neurological disorder characterized by a loss of ability to execute and carry out skilled movements and gestures despite intact motor and sensory systems, coordination and comprehension.

Upper limb apraxia comprises a wide spectrum of higher motor disorders caused by acquired brain disease, affecting the performance of skilled movements carried out by the upper limbs.

Few data are available on the effectiveness of interventions in this disorder and no exists studies that implement a mixed intervention (rehabilitative and compensatory ) of Occupational Therapy in these patients at home.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Barthel index at 8 weeks
timeFrame: Eight weeks
measure: Change from Baseline in Barthel index at 16 weeks
timeFrame: Sixteen weeks
Secondary outcomes:
measure: Change from baseline in observation and scoring of ADL-Activities at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 8 weeks.
timeFrame: Eight weeks
measure: Change from baseline in Quality of life scale for stroke (ECVI-38) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline in observation and scoring of ADL-Activities at 16 weeks
timeFrame: Sixteen weeks
measure: Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from baseline in De Renzi Test (ideational apraxia) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from baseline in De Renzi Test (ideomotor apraxia) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from baseline in recognition of gestures (Smania, 2000) at 16 weeks
timeFrame: Sixteen weeks
measure: Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 16 weeks.
timeFrame: Sixteen weeks
measure: Change from baseline in Quality of life scale for stroke (ECVI-38) at 16 weeks
timeFrame: Sixteen weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada and University hospital "San Cecilio"
Study officials:
affiliation: Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
name: Mª Encarnacion ME Aguilar, PdH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.