Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury

NCT ID: NCT04166617

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-12

Study Completion Date

2021-11-11

Brief Summary

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The affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. The use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. So that, the goal of this investigation is to evaluate the system use effectiveness of the Leap Motion Controller® in the treatment on the upper limb on patients with neurological disease.

Detailed Description

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Conditions

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Stroke Treatment Adherence Patient Satisfaction Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Conventional therapy

Conventional physical therapy for upper limb in stroke patients

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

conventional physcial therapy rehabilitation for the upper limb

Leap motion plus conventional therapy

Leap motion plus conventional physical therapy for upper limb in stroke patients

Group Type EXPERIMENTAL

Leap motion plus conventional therapya

Intervention Type OTHER

leap motion plus conventional physcial therapy rehabilitation for the upper limb

Interventions

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Conventional therapy

conventional physcial therapy rehabilitation for the upper limb

Intervention Type OTHER

Leap motion plus conventional therapya

leap motion plus conventional physcial therapy rehabilitation for the upper limb

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* people aged between 30 and 70 years old;
* with a confirmed diagnosis of brain damage (\>6 months);
* UL motor impairment with a Fugl-Meyer score≥16;
* a modified Ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb

Exclusion Criteria

* the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the Mini-mental Test;
* refusal to participate in the study;
* visual impairment not correctable by glasses.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

Full proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

References

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Aguilera-Rubio A, Alguacil-Diego IM, Mallo-Lopez A, Jardon Huete A, Ona ED, Cuesta-Gomez A. Use of low-cost virtual reality in the treatment of the upper extremity in chronic stroke: a randomized clinical trial. J Neuroeng Rehabil. 2024 Jan 22;21(1):12. doi: 10.1186/s12984-024-01303-2.

Reference Type DERIVED
PMID: 38254147 (View on PubMed)

Other Identifiers

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01/06/2018

Identifier Type: -

Identifier Source: org_study_id

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