StrokeNCT02199093
Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke
A study testing Functional Rehabilitation of apraxia and Traditional health educative protocol in people with Stroke and Apraxias, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- What is being tested?
- Functional Rehabilitation of apraxia and Traditional health educative protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Granada and University hospital "San Cecilio"
Granada, 18012
About this study
Official title: Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke: Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Functional Rehabilitation of apraxia, Traditional health educative protocol
- Keywords
- MeSH terms:, Apraxias, Apraxia, Ideomotor, Stroke, Cerebral Stroke, Rehabilitation, Occupational therapy, Treatment Outcome, Activities of Daily Living
- Medical subject headings
- Stroke, Apraxias, Apraxia, Ideomotor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Rehabilitation of apraxiaOther
Also called Intervention of occupational therapy in 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 protocolOther
Also called Traditional intervention in apraxia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional health educative protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eight weeks
Change from Baseline in Barthel index at 16 weeks
Measured: Sixteen weeks
Secondary outcomes (14)
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.
Measured: Eight weeks
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).
Measured: Eight weeks
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).
Measured: Eight weeks
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).
Measured: Eight weeks
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).
Measured: Eight weeks
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).
Measured: Eight weeks
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.
Measured: Eight weeks
Change from baseline in observation and scoring of ADL-Activities at 16 weeks
Measured: Sixteen weeks
Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 16 weeks
Measured: Sixteen weeks
Change from baseline in De Renzi Test (ideational apraxia) at 16 weeks
Measured: Sixteen weeks
Change from baseline in De Renzi Test (ideomotor apraxia) at 16 weeks
Measured: Sixteen weeks
Change from baseline in recognition of gestures (Smania, 2000) at 16 weeks
Measured: Sixteen weeks
Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 16 weeks.
Measured: Sixteen weeks
Change from baseline in Quality of life scale for stroke (ECVI-38) at 16 weeks
Measured: Sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Mª Encarnacion ME Aguilar, PdH, Principal investigator, Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199093
- Sponsor's protocol ID
- Upper_limb_apraxia
- Status last verified
- Oct 2018
- First submitted
- 21 Jul 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33485836Perez-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.
PubMed 26542104
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Rehabilitation of Upper Limb Apraxia in Patients Poststroke: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02199093
- Acronym / sponsor ID
- Upper_limb_apraxia
- Keywords
- MeSH terms:, Apraxias, Apraxia, Ideomotor, Stroke, Cerebral Stroke, Rehabilitation, Occupational therapy, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio
- Study start
- May 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Rehabilitation of apraxia | Experimental | Other: Functional Rehabilitation of apraxiaThe 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. |
| Traditional health educative protocol | Active comparator | Other: Traditional health educative protocolControl 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. |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Rehabilitation of apraxiaAlso: Intervention of occupational therapy in apraxiaThe 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. | Other | Functional Rehabilitation of apraxia |
| Traditional health educative protocolAlso: Traditional intervention in apraxiaThe 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. | Other | Traditional health educative protocol |
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
14 secondary outcomes
Change from baseline in observation and scoring of ADL-Activities at 8 weeks
Time frame: Eight weeks
Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 8 weeks
Time frame: Eight weeks
Change from baseline in De Renzi Test (ideational apraxia) at 8 weeks
Time frame: Eight weeks
Change from baseline in De Renzi Test (ideomotor apraxia) at 8 weeks
Time frame: Eight weeks
Change from baseline in recognition of gestures (Smania, 2000) at 8 weeks
Time frame: Eight weeks
Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 8 weeks.
Time frame: Eight weeks
Change from baseline in Quality of life scale for stroke (ECVI-38) at 8 weeks
Time frame: Eight weeks
Change from baseline in observation and scoring of ADL-Activities at 16 weeks
Time frame: Sixteen weeks
Change from baseline in the Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) at 16 weeks
Time frame: Sixteen weeks
Change from baseline in De Renzi Test (ideational apraxia) at 16 weeks
Time frame: Sixteen weeks
Change from baseline in De Renzi Test (ideomotor apraxia) at 16 weeks
Time frame: Sixteen weeks
Change from baseline in recognition of gestures (Smania, 2000) at 16 weeks
Time frame: Sixteen weeks
Change from baseline in Comprehensive assessment of gesture production: Test of upper limb apraxia (TULIA) at 16 weeks.
Time frame: Sixteen weeks
Change from baseline in Quality of life scale for stroke (ECVI-38) at 16 weeks
Time frame: Sixteen weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Derived from this study: PubMed 33485836Aguilar-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.
- Derived from this study: PubMed 26542104Perez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mª Encarnacion ME Aguilar, PdH principal investigator
Department of Physiotherapy. Faculty of Sciences of Health. University of Granada (Granada). Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Rehabilitation of apraxia and Traditional health educative protocol in people with Stroke and Apraxias, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Barthel index at 8 weeks (time frame: Eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02199093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.