ULReed: Upper Limb Reeducation Across Life Span

• Sponsor: Instituto Politécnico de Leiria (Other)
• Overall Status: Completed
• CT.gov ID: NCT03997591
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Mar 1, 2019
• Actual Primary Completion Date: May 29, 2019
• Actual Study Completion Date: May 29, 2019

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Video analysis of feeding performance [6 weeks]

   performance of several feeding steps

Secondary Outcome Measures

1. Frontal assessment battery [6 weeks]

   Assessment of Executive Functions

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Politécnico de Leiria	Leiria		Portugal

Sponsors and Collaborators

• Instituto Politécnico de Leiria

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - May 10, 2019

More Information

Publications

None provided.

• Responsible Party: Marlene Rosa, Clinical Professor, Instituto Politécnico de Leiria
• ClinicalTrials.gov Identifier: NCT03997591
• Other Study ID Numbers: IPL10062019
• First Posted: Jun 25, 2019
• Last Update Posted: Jun 25, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marlene Rosa, Clinical Professor, Instituto Politécnico de Leiria: eating; upper limb; reeducation
• Additional relevant MeSH terms: Cerebral Palsy; Feeding and Eating Disorders; Cognitive Dysfunction

Study Results

No Results Posted as of Jun 25, 2019