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

Primary Purpose

Stroke, Treatment Adherence, Patient Satisfaction

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional therapy
Leap motion plus conventional therapya
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional therapy

Leap motion plus conventional therapy

Arm Description

Conventional physical therapy for upper limb in stroke patients

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

Outcomes

Primary Outcome Measures

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)
Jamar
Jamar® hydraulic hand dynamometer was used to measure grip strength.
Box and blocks
Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.

Secondary Outcome Measures

Adherence to the therapy sessions
the attendance rate (%) for therapy sessions
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

Full Information

First Posted
November 11, 2019
Last Updated
November 14, 2019
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT04166617
Brief Title
Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
Official Title
Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 11, 2020 (Anticipated)
Study Completion Date
November 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Treatment Adherence, Patient Satisfaction, Brain Injuries, Traumatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Conventional physical therapy for upper limb in stroke patients
Arm Title
Leap motion plus conventional therapy
Arm Type
Experimental
Arm Description
Leap motion plus conventional physical therapy for upper limb in stroke patients
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
conventional physcial therapy rehabilitation for the upper limb
Intervention Type
Other
Intervention Name(s)
Leap motion plus conventional therapya
Intervention Description
leap motion plus conventional physcial therapy rehabilitation for the upper limb
Primary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
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)
Time Frame
8 weeks
Title
Jamar
Description
Jamar® hydraulic hand dynamometer was used to measure grip strength.
Time Frame
8 weeks
Title
Box and blocks
Description
Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adherence to the therapy sessions
Description
the attendance rate (%) for therapy sessions
Time Frame
8 weeks
Title
Questionary of Patient Satifaction
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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