NCT03890965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

March 23, 2019

Last Update Submit

April 5, 2020

Conditions

Keywords

strokePhysical therapyneurological handVojta therapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Study Arms (1)

Experimental

EXPERIMENTAL

Adult patients with chronic sequelae in the upper limb after neurological damage

Other: Reflex locomoction therapy

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sequelae in the upper limb after neurological damage.
  • Understanding and oral expression preserved.
  • More than a year after the episode.
  • Possibility of walking

You may not qualify if:

  • Aphasia.
  • Concomitant diseases: Diabetes and arthritis of the hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NUMEN Foundation

Madrid, España, 28027, Spain

Location

MeSH Terms

Conditions

Nervous System DiseasesStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Luis Perales Lopez, Doctor

    NUMEN Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pretest-posttest trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy service coordinator

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 26, 2019

Study Start

May 29, 2019

Primary Completion

July 30, 2019

Study Completion

September 25, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations