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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.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02042508
Enrollment
6
Registered
2014-01-23
Start date
2016-02-02
Completion date
Unknown
Last updated
2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

OTHERstrengthening
OTHERhybrid training programme

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frame
Maximal oxygen consumption (VO2max) measured during an incremental maximum effort testChange from baseline in VO2max at 9 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026