- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890965
Effects of the Application of a Reflex Locomotion Program in the Neurological Hand
Effects of the Application of a Reflex Locomotion Program on Sitting in the Neurological Hand of the Chronic Adult Patient
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
España
-
Madrid, España, Spain, 28027
- NUMEN Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sequelae in the upper limb after neurological damage.
- Understanding and oral expression preserved.
- More than a year after the episode.
- Possibility of walking
Exclusion Criteria:
- Aphasia.
- Concomitant diseases: Diabetes and arthritis of the hand.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Adult patients with chronic sequelae in the upper limb after neurological damage
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 weeks for mild grade and 3 months for moderate degree
|
|
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.
|
2 weeks for mild grade and 3 months for moderate degree.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis Perales Lopez, Doctor, NUMEN Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUMEN1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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