Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke

Stroke Clinical Trial

Official title:

Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199093
• Other study ID #: Upper_limb_apraxia
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apraxias
• Stroke

Intervention

Other:
• Functional Rehabilitation of apraxia
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.
• Traditional health educative protocol
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.

Locations

Country	Name	City	State
Spain	University of Granada and University hospital "San Cecilio"	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Hospital Clinico Universitario San Cecilio

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from Baseline in Barthel index at 16 weeks		Sixteen weeks
Secondary	Change from baseline in observation and scoring of ADL-Activities at 8 weeks	It is a test to observe the activities of daily living with a system of standardized observations specially developed for the assessment of disability provoked by apraxia syndrome. The overall score has a range of totally dependent (0) to absolutely independent (3). Considering the reliability of each assessed activity, the intraclass correlation coefficient range is from 0.62 to 0.98. The lowest Kappa values 0.70, indicating considerable agreement.	Eight weeks
Secondary	Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks	It is a scale to assess the ability of the person to perform instrumental activities necessary to live independently in the community. It is a heteroadministered tool. The maximum score is 8 points, this indicates complete independence, a score of 6-7 means mild dependence, 4-5 moderate dependence, 2-3 severe dependency and 0-1 total dependence. Has a high inter and intraobserver coefficient of reproducibility (0.94).	Eight weeks
Secondary	Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks	This test requires the use of real objects. Patients are asked by words and gestures to take the object in their hands and to show how they would use it. Two points are assigned for immediate correct response; 1 point if correct performance is preceded by hesitation and by a protracted latency period during which wrong or unsuccessful movements are present, or performance is conceptually correct, but actual movements are somewhat inaccurate or awkward; 0 points for any other type of error (score, 0-14).	Eight weeks
Secondary	Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks	In this test, the patients are asked to reproduce a wide variety of intransitive gestures (ie, not requiring use of objects). Gestures are symbolic (eg, sign of O.K.) or non symbolic (hand under the chin). The patients are assigned 3, 2, or 1 points if they have errors in performing on the first, second, or third demonstration; if all demonstrations are unsatisfactory, the patient is credited 0 points. The test included 24 items (score, 0-72).	Eight weeks
Secondary	Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks	Recognition of gestures is tested both for transitive or intransitive-symbolic gestures. As for transitive gestures, the patient is given 3 pictures showing an action performed respectively with the adequate object, with a semantically related but inappropriate object, or with a semantically unrelated and inappropriate object. Patients are required to indicate the picture in which the correct transitive gesture is reproduced. As for intransitive symbolic gestures, the patient is given 3 pictures showing different symbolic gestures, 1 of which is related to a context represented in another picture. The remaining 2 pictures show gestures with or without postural affinities with the correct gesture. The patient is requested to indicate the picture showing the gesture related to the context. The test includes 5 transitive and 5 intransitive gesture recognition trials. One point is given for each correct response (score, 0-10).	Eight weeks
Secondary	Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 8 weeks.	This test has a total of 48 items for the imitation of gestures and simulation of no symbolic gestures (meaningless), intransitive (communicative) and transitive (related objects), grouped in 6 subtest. It has a Likert scale of 0-6 points per item, with a total score ranging from 0 to 240 points. This test has proven to be reliable and valid to assess the production of gestures. It can be therefore easily applied and therefore useful for research and clinical practice purposes. This tool has demonstrated good to excellent internal consistency, test-retest reliability, both at the level of the six subtest and individual level of the items. Construct validity was demonstrated by a high correlation with the test Renzi (r = 0.82).	Eight weeks
Secondary	Change from baseline in Quality of life scale for stroke (ECVI-38) at 8 weeks	This is a self-administered questionnaire by the patient, although in cases where the patient is unable to read and understand the questions, should be performed by a relative or the primary caregiver. It has 38 items grouped into 8 subscales: physical, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living, social and family functioning, plus two additional questions about involvement in sexual relationships and occupational activity. Responses are categorized depending on the percentage result of the total maximum score of 100 points. Less than 25% means without affectation; between 25-50%, mild disease; between 50-75%, moderate impairment; equal or more than 75%, severely affected.	Eight weeks
Secondary	Change from baseline in observation and scoring of ADL-Activities at 16 weeks		Sixteen weeks
Secondary	Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 16 weeks		Sixteen weeks
Secondary	Change from baseline in De Renzi Test (ideational apraxia) at 16 weeks		Sixteen weeks
Secondary	Change from baseline in De Renzi Test (ideomotor apraxia) at 16 weeks		Sixteen weeks
Secondary	Change from baseline in recognition of gestures (Smania, 2000) at 16 weeks		Sixteen weeks
Secondary	Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 16 weeks.		Sixteen weeks
Secondary	Change from baseline in Quality of life scale for stroke (ECVI-38) at 16 weeks		Sixteen weeks