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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Brain Injuries, Traumatic; Treatment Adherence; Patient Satisfaction
• Intervention / Treatment: Other: Conventional therapy; Other: Leap motion plus conventional therapya

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Universidad Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy; Conventional physical therapy for upper limb in stroke patients	Other: Conventional therapy; conventional physcial therapy rehabilitation for the upper limb
Experimental: Leap motion plus conventional therapy; Leap motion plus conventional physical therapy for upper limb in stroke patients	Other: Leap motion plus conventional therapya; leap motion plus conventional physcial therapy rehabilitation for the upper limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the therapy sessions	the attendance rate (%) for therapy sessions	8 weeks
Questionary of Patient Satifaction	which evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered	8 weeks

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Anticipated): November 11, 2020
• Study Completion (Anticipated): November 11, 2021

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 01/06/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No