Neurological DisorderNCT03890965
Effects of the Application of a Reflex Locomotion Program in the Neurological Hand
A study testing Reflex locomoction therapy in people with Neurological Disorder, run by NUMEN Foundation at 1 site in Spain.
Trial summary
The recovery of the function of the hand is one of the most important aspects for patients who have suffered the consequences of neurological damage. Currently there are numerous therapeutic procedures aimed at rehabilitation that have scientific evidence such as restrictive therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorder
- What is being tested?
- Reflex locomoction therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2019to 25 Sep 2019
- 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
- Sequelae in the upper limb after neurological damage.
- Understanding and oral expression preserved.
- More than a year after the episode.
- Possibility of walking
Who cannot join
- Aphasia.
- Concomitant diseases: Diabetes and arthritis of the hand.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Application of a Reflex Locomotion Program on Sitting in the Neurological Hand of the Chronic Adult Patient
The recovery of the function of the hand is one of the most important aspects for patients who have suffered the consequences of neurological damage. Currently there are numerous therapeutic procedures aimed at rehabilitation that have scientific evidence such as restrictive therapy. However, dysfunction of the upper limb has an impact on the whole body that is not always taken into consideration.
Read the detailed description
The intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of Vojta therapy.
Description of the sitting posture: the back in axial extension with the shoulders located in front of the hips.
The elbows must be supported with the medial epicondyl in contact on a table, whose height is at the level of the end of the patient's sternum.
The forearms are placed prone with the palms facing the surface. In this position we place a rubber sphere 3 centimeters in diameter under the pisiform of one of the patient's wrists.
The reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. Simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. This foot will be the opposite of the wrist that has the sphere under the pisiform.
It is a cross-stimulation, that is, pisiform in one hand together with the load in the heel of the opposite side.
Alternating each diagonal 4 times, 5 minutes each. Total session 20 minutes, 2 times per day, every day according to degree of affectation
The duration of the study will depend on the degree of involvement: mild 2 weeks, moderate 3 months.
- Conditions
- Neurological Disorder
- Being tested
- Reflex locomoction therapy
- Keywords
- stroke, Physical therapy, neurological hand, Vojta therapy
- Medical subject headings
- Nervous System Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex locomoction therapyOther
The intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of Vojta therapy.
The reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. Simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. This foot will be the opposite of the wrist that has the sphere under the pisiform.
Alternating each diagonal 4 times, 5 minutes each. Total session 20 minutes, 2 times x day, every day according to degree of affectation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Adult patients with chronic sequelae in the upper limb after neurological damage Receives: Other: Reflex locomoction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
kinesiological test of the upper limb
Shoulder: flexion and maximum abduction. Forearm: Supination / pronation. Wrist: maximum dorsal flexion. Hand: finger extension
Measured: 2 weeks for mild grade and 3 months for moderate degree
The Box and Block Test
The Box and Block Test is a functional outcome measure that is commonly used across multiple clinical populations due to its benefits of ease and speed of implementation; reliable, objective measurement; and repetition of motion.
Measured: 2 weeks for mild grade and 3 months for moderate degree.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start29 May 2019
- Primary completion30 Jul 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pretest-posttest trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NUMEN Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Perales Lopez, NUMEN Foundation
- Investigators
- Luis Perales Lopez, Doctor, Principal investigator, NUMEN Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890965
- Sponsor's protocol ID
- NUMEN1
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Application of a Reflex Locomotion Program on Sitting in the Neurological Hand of the Chronic Adult Patient
- ClinicalTrials.gov ID
- NCT03890965
- Acronym / sponsor ID
- NUMEN1
- Conditions
- Neurological Disorder
- Keywords
- stroke, Physical therapy, neurological hand, Vojta therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NUMEN FoundationUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 26 Mar 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 recovery of the function of the hand is one of the most important aspects for patients who have suffered the consequences of neurological damage. Currently there are numerous therapeutic procedures aimed at rehabilitation that have scientific evidence such as restrictive therapy. However, dysfunction of the upper limb has an impact on the whole body that is not always taken into consideration.
Detailed description
The intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of Vojta therapy.
Description of the sitting posture: the back in axial extension with the shoulders located in front of the hips.
The elbows must be supported with the medial epicondyl in contact on a table, whose height is at the level of the end of the patient's sternum.
The forearms are placed prone with the palms facing the surface. In this position we place a rubber sphere 3 centimeters in diameter under the pisiform of one of the patient's wrists.
The reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. Simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. This foot will be the opposite of the wrist that has the sphere under the pisiform.
It is a cross-stimulation, that is, pisiform in one hand together with the load in the heel of the opposite side.
Alternating each diagonal 4 times, 5 minutes each. Total session 20 minutes, 2 times per day, every day according to degree of affectation
The duration of the study will depend on the degree of involvement: mild 2 weeks, moderate 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pretest-posttest trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Reflex locomoction therapyAdult patients with chronic sequelae in the upper limb after neurological damage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sequelae in the upper limb after neurological damage.
- Understanding and oral expression preserved.
- More than a year after the episode.
- Possibility of walking
Key exclusion criteria (2 listed)
- Aphasia.
- Concomitant diseases: Diabetes and arthritis of the hand.
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 |
|---|---|---|
| Reflex locomoction therapyThe intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of Vojta therapy. The reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. Simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. This foot will be the opposite of the wrist that has the sphere under the pisiform. Alternating each diagonal 4 times, 5 minutes each. Total session 20 minutes, 2 times x day, every day according to degree of affectation. | Other | Experimental |
Primary outcome
kinesiological test of the upper limb
Time frame: 2 weeks for mild grade and 3 months for moderate degree
Shoulder: flexion and maximum abduction. Forearm: Supination / pronation. Wrist: maximum dorsal flexion. Hand: finger extension
The Box and Block Test
Time frame: 2 weeks for mild grade and 3 months for moderate degree.
The Box and Block Test is a functional outcome measure that is commonly used across multiple clinical populations due to its benefits of ease and speed of implementation; reliable, objective measurement; and repetition of motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
Luis Perales Lopez, Doctor principal investigator
NUMEN Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflex locomoction therapy in people with Neurological Disorder, run by NUMEN Foundation 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 2 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: finished, as of the sponsor's last update on 7 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
kinesiological test of the upper limb (time frame: 2 weeks for mild grade and 3 months for moderate degree). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.