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

Not Applicable

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

• Registration Number: NCT04166617
• Lead Sponsor: Universidad Rey Juan Carlos

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-11
• Study Start: 2019-11-12
• Study First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Study First Posted: 2019-11-18
• Last Update Posted: 2019-11-18
• Primary Completion: 2020-11-11
• Study Completion: 2021-11-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	Conventional therapy	Conventional physical therapy for upper limb in stroke patients
Leap motion plus conventional therapy	Leap motion plus conventional therapya	Leap motion plus conventional physical therapy for upper limb in stroke patients

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	8 weeks	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)
Box and blocks	8 weeks	Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.
Jamar	8 weeks	Jamar® hydraulic hand dynamometer was used to measure grip strength.

Secondary Outcome Measures

Name	Time	Method
Questionary of Patient Satifaction	8 weeks	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
Adherence to the therapy sessions	8 weeks	the attendance rate (%) for therapy sessions

Trial Locations

Locations (1)

Universidad Rey Juan Carlos; 🇪🇸 Alcorcón, Madrid, Spain