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Upper Limb Reeducation Across Life Span (ULReed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997591
Recruitment Status : Completed
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Marlene Rosa, Instituto Politécnico de Leiria

Brief Summary:

Program Ready2E.A.T. was developed to be tested in the upper limb reeducation on population at risk, such as:

  • Children with dysfunction
  • Cognitive impaired elderly
  • Dementia people

Condition or disease Intervention/treatment
Upper Extremity Dysfunction Dementia Cerebral Palsy Cognitive Decline Eating Disorders Other: Ready2E.A.T. PROGRAM

Detailed Description:

Program Ready2E.A.T. consists on the training of specific upper limb tasks, including:

  • reaching during attention tasks
  • reaching during memory tasks
  • reaching during sequential motor tasks
  • reaching during fine hand movements

This program has been tested as a measure of functional status (cognitive and motor habilities) in population with different risks; It also has been tested as an effective program for reeducation in cognitive affected population.


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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Ready2E.A.T. in Risk Populations
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : May 29, 2019

Group/Cohort Intervention/treatment
Conventional therapy
Group doing conventional rehabilitation was assessed at T0 and then after 6 weeks of conventional therapy (occupational therapy, physical therapy, aquatic therapy, musicotherapy, others)
Other: Ready2E.A.T. PROGRAM

Training tasks based on:

reaching activities during attention tasks, memory tasks, sequential tasks This group was assessed at T0 and then after 6 weeks of conventional therapy.


Ready2E.A.T. therapy
Group doing Ready2E.A.T. program received a mean of 1 hour per week and was assessed at T0 and then after 6 weeks of this program implementation.
Other: Ready2E.A.T. PROGRAM

Training tasks based on:

reaching activities during attention tasks, memory tasks, sequential tasks This group was assessed at T0 and then after 6 weeks of conventional therapy.





Primary Outcome Measures :
  1. Video analysis of feeding performance [ Time Frame: 6 weeks ]
    performance of several feeding steps


Secondary Outcome Measures :
  1. Frontal assessment battery [ Time Frame: 6 weeks ]
    Assessment of Executive Functions



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Old people and children dependent in feeding activity.
Criteria

Inclusion Criteria:

  • people with 60years old with cognitive decline
  • children aging 6-10 years old with cognitive and motor dysfunction
  • dysfunction in feeding participation

Exclusion Criteria:

  • participants that do not understand 2 simnultaneous verbal commands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997591


Locations
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Portugal
Instituto Politécnico de Leiria
Leiria, Portugal
Sponsors and Collaborators
Instituto Politécnico de Leiria
  Study Documents (Full-Text)

Documents provided by Marlene Rosa, Instituto Politécnico de Leiria:
Statistical Analysis Plan  [PDF] May 10, 2019


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Responsible Party: Marlene Rosa, Clinical Professor, Instituto Politécnico de Leiria
ClinicalTrials.gov Identifier: NCT03997591     History of Changes
Other Study ID Numbers: IPL10062019
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marlene Rosa, Instituto Politécnico de Leiria:
eating
upper limb
reeducation
Additional relevant MeSH terms:
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Cerebral Palsy
Feeding and Eating Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Brain Damage, Chronic
Cognition Disorders