StrokeNCT04166617
Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
A study testing Conventional therapy and Leap motion plus conventional therapya in people with Stroke and Treatment Adherence, run by Universidad Rey Juan Carlos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Treatment Adherence, Patient Satisfaction
- What is being tested?
- Conventional therapy and Leap motion plus conventional therapya
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Nov 2019to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Conventional therapy, Leap motion plus conventional therapya
- Medical subject headings
- Stroke, Treatment Adherence and Compliance, Patient Satisfaction, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyOther
conventional physcial therapy rehabilitation for the upper limb
Leap motion plus conventional therapyaOther
leap motion plus conventional physcial therapy rehabilitation for the upper limb
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Conventional physical therapy for upper limb in stroke patients Receives: Other: Conventional therapy |
| Leap motion plus conventional therapy | Experimental | Leap motion plus conventional physical therapy for upper limb in stroke patients Receives: Other: Leap motion plus conventional therapya |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Jamar
Jamar® hydraulic hand dynamometer was used to measure grip strength.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
Adherence to the therapy sessions
the attendance rate (%) for therapy sessions
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start12 Nov 2019
- Primary completion11 Nov 2020 (estimated)
- Study completion11 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166617
- Sponsor's protocol ID
- 01/06/2018
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38254147
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04166617
- Acronym / sponsor ID
- 01/06/2018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 11 Nov 2020 (estimated)
- Study completion
- 11 Nov 2021 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Conventional therapyConventional physical therapy for upper limb in stroke patients |
| Leap motion plus conventional therapy | Experimental | Other: Leap motion plus conventional therapyaLeap motion plus conventional physical therapy for upper limb in stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional therapyconventional physcial therapy rehabilitation for the upper limb | Other | Conventional therapy |
| Leap motion plus conventional therapyaleap motion plus conventional physcial therapy rehabilitation for the upper limb | Other | Leap motion plus conventional therapy |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: 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)
Jamar
Time frame: 8 weeks
Jamar® hydraulic hand dynamometer was used to measure grip strength.
Box and blocks
Time frame: 8 weeks
Box and Blocks Test (BBT) was performed to measure unilateral gross manual dexterity in both the less and more affected side.
2 secondary outcomes
Adherence to the therapy sessions
Time frame: 8 weeks
Questionary of Patient Satifaction
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Derived from this study: PubMed 38254147Aguilera-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional therapy and Leap motion plus conventional therapya in people with Stroke and Treatment Adherence, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.