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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166617
• Other study ID #: 01/06/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: November 11, 2021

Study information

• Verified date: November 2019
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Patient Satisfaction
• Stroke
• Treatment Adherence
• Wounds and Injuries

Intervention

Other:
• Conventional therapy
conventional physcial therapy rehabilitation for the upper limb
• Leap motion plus conventional therapya
leap motion plus conventional physcial therapy rehabilitation for the upper limb

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Jamar	Jamar® hydraulic hand dynamometer was used to measure grip strength.	8 weeks
Primary	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	Adherence to the therapy sessions	the attendance rate (%) for therapy sessions	8 weeks
Secondary	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