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

NCT04166617 | Unknown

• 1 other identifier: 01/06/2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Treatment Adherence; Patient Satisfaction; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (3)

• Action Research Arm Test (ARAT)

  Shoulder Pain - Physioplus Objective The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning)

  8 weeks

• Jamar

  Jamar® hydraulic hand dynamometer was used to measure grip strength.

  8 weeks

• Box and blocks

  Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.

  8 weeks

Secondary Outcomes (2)

• Adherence to the therapy sessions

  8 weeks

• Questionary of Patient Satifaction

  8 weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Conventional physical therapy for upper limb in stroke patients

Other: Conventional therapy

Leap motion plus conventional therapy

EXPERIMENTAL

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

Other: Leap motion plus conventional therapya

Interventions

Conventional therapy OTHER

conventional physcial therapy rehabilitation for the upper limb

Conventional therapy

Leap motion plus conventional therapya OTHER

leap motion plus conventional physcial therapy rehabilitation for the upper limb

Leap motion plus conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 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.

  PMID: 38254147 DERIVED

MeSH Terms

Conditions

Stroke; Treatment Adherence and Compliance; Patient Satisfaction; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full proffesor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: November 12, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2021
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

ES (1)