Upper Extremity DysfunctionULReedNCT03997591
Upper Limb Reeducation Across Life Span
An observational study of Upper Extremity Dysfunction and Dementia, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Extremity Dysfunction, Dementia, Cerebral Palsy
- What is being tested?
- Ready2E.A.T. PROGRAM
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2019to 29 May 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Old people and children dependent in feeding activity.
Who may be able to join
- people with 60years old with cognitive decline
- children aging 6-10 years old with cognitive and motor dysfunction
- dysfunction in feeding participation
Who cannot join
- participants that do not understand 2 simnultaneous verbal commands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ready2E.A.T. in Risk Populations
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
Read the 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.
- Conditions
- Upper Extremity Dysfunction, Dementia, Cerebral Palsy, Cognitive Decline, Eating Disorders
- Being tested
- Ready2E.A.T. PROGRAM
- Keywords
- eating, upper limb, reeducation
- Medical subject headings
- Dementia, Cerebral Palsy, Cognitive Dysfunction, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready2E.A.T. PROGRAMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Ready2E.A.T. PROGRAM | |
| 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. Receives: Other: Ready2E.A.T. PROGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video analysis of feeding performance
performance of several feeding steps
Measured: 6 weeks
Secondary outcomes (1)
Frontal assessment battery
Assessment of Executive Functions
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Mar 2019
- Primary completion29 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Rosa, Instituto Politécnico de Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997591
- Sponsor's protocol ID
- IPL10062019
- Acronym
- ULReed
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ready2E.A.T. in Risk Populations
- ClinicalTrials.gov ID
- NCT03997591
- Acronym / sponsor ID
- ULReed / IPL10062019
- Conditions
- Upper Extremity Dysfunction, Dementia, Cerebral Palsy, Cognitive Decline, Eating Disorders
- Keywords
- eating, upper limb, reeducation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 25 Jun 2019 (actual)
- 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.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | – | Other: Ready2E.A.T. PROGRAMGroup doing conventional rehabilitation was assessed at T0 and then after 6 weeks of conventional therapy (occupational therapy, physical therapy, aquatic therapy, musicotherapy, others) |
| Ready2E.A.T. therapy | – | Other: Ready2E.A.T. PROGRAMGroup 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Old people and children dependent in feeding activity.
Key inclusion criteria (3 listed)
- people with 60years old with cognitive decline
- children aging 6-10 years old with cognitive and motor dysfunction
- dysfunction in feeding participation
Key exclusion criteria (1 listed)
- participants that do not understand 2 simnultaneous verbal commands
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 |
|---|---|---|
| Ready2E.A.T. PROGRAMTraining 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. | Other | Conventional therapy, Ready2E.A.T. therapy |
Primary outcome
Video analysis of feeding performance
Time frame: 6 weeks
performance of several feeding steps
1 secondary outcome
Frontal assessment battery
Time frame: 6 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 25 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Dysfunction and Dementia, run by Instituto Politécnico de Leiria at 1 site in Portugal.
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 3 inclusion and 1 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 25 Jun 2019. 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 Portugal. 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?
Video analysis of feeding performance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2019.