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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.

Current Primary Outcome:

• Change from Baseline in Barthel index at 8 weeks [ Time Frame: Eight 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.
• Change from Baseline in Barthel index at 16 weeks [ Time Frame: Sixteen weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in observation and scoring of ADL-Activities at 8 weeks [ Time Frame: Eight 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.
• Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks [ Time Frame: Eight 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).
• Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks [ Time Frame: Eight 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).
• Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks [ Time Frame: Eight 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).
• Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks [ Time Frame: Eight 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).
• Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 8 weeks. [ Time Frame: Eight 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).
• Change from baseline in Quality of life scale for stroke (ECVI-38) at 8 weeks [ Time Frame: Eight 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.
• Change from baseline in observation and scoring of ADL-Activities at 16 weeks [ Time Frame: Sixteen weeks ]
• Same as current
  
  Information By: Universidad de Granada
  

  Dates:
  Date Received: July 21, 2014
  Date Started: May 2014
  Date Completion: July 2016
  Last Updated: May 10, 2016
  Last Verified: May 2016