Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

NCT ID: NCT02042508

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-02

Brief Summary

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This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.

Detailed Description

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Conditions

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Chronic Paraplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Paraplegic patients

Group Type EXPERIMENTAL

strengthening

Intervention Type OTHER

hybrid training programme

Intervention Type OTHER

Interventions

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strengthening

Intervention Type OTHER

hybrid training programme

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female patients with paraplegia, ageb between 18 and 45 years
* Body mass index (BMI) between 18.5 and 29.9
* 2 to 15 years after the accident, ASIA A or B, lesion situated between T3 and T12
* Medically stable
* Able to follow instructions
* Persons who have provided written informed consent

Exclusion Criteria

* Persons without national health insurance cover
* Arterial blood pressure \> 140/90 mmHg, arrythmia, heart disease, diabetes, impaired kidney function, cancer
* smoking-induced intoxication,
* Medical treatment for cardiovascular disease or antidepressants
* Orthostatic hypotension with a symptomatic fall in arterial pressure \> 30 mmHg in the vertical position
* Grade 2 or more pressure sores
* Other associated neurological diseases (e.g. cerebrovascular accident, peripheral neuropathy, myopathy)
* Any disease affecting the shoulder that may compromise the ability to use the rowing machine.
* Coagulation disorders;
* Presence of an implanted electronic device
* Epilepsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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CASILLAS PARI 2011

Identifier Type: -

Identifier Source: org_study_id

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