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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03890965
Other study ID # NUMEN1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date September 25, 2019

Study information

Verified date April 2020
Source NUMEN Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. However, dysfunction of the upper limb has an impact on the whole body that is not always taken into consideration.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 25, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Reflex locomoction therapy
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.

Locations

Country Name City State
Spain NUMEN Foundation Madrid España

Sponsors (1)

Lead Sponsor Collaborator
NUMEN Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary kinesiological test of the upper limb 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
Primary 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. 2 weeks for mild grade and 3 months for moderate degree.
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