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.

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Brief Title

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.

Official Title

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.

Brief Summary

      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.
    



Study Type

Interventional


Primary Outcome

Maximal oxygen consumption (VO2max) measured during an incremental maximum effort test


Condition

Chronic Paraplegia

Intervention

strengthening

Study Arms / Comparison Groups

 Paraplegic patients
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

6

Start Date

February 2, 2016


Primary Completion Date

February 2, 2016

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 45 Years


Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02042508

Organization ID

CASILLAS PARI 2011


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire Dijon


Study Sponsor

, , 


Verification Date

May 2019