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Performance Developement of Patients With Paraplegia During First Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405558
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Study Description
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Brief Summary:
A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.

Condition or disease Intervention/treatment
Physical Activity Other: No intervention

Study Design
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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of an Individually Tailored Endurance Training on the Performance Developement of Patients With Paraplegia During First Rehabilitation: an Observational Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 31, 2023
Actual Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine

Outcome Measures
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Primary Outcome Measures :
  1. Peak power [ Time Frame: 10min ]
    Maximal performance reached during incremental exercise on an arm-crank ergometer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a paraplegia during the first rehabilitation
Criteria

Inclusion Criteria:

  • Written informed consent
  • male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)
  • Age 18-65 years
  • Manual wheelchair user
  • Patient during first rehabilitation

Exclusion Criteria:

  • BMI ≥ 30
  • unable to use an arm-crank Ergometer due to e.g. spasticity
  • physical impairment, which makes it impossible to perform an arm-crank ergometry
  • Progressive disease (g.g. tumor, MS)
  • Ventilator dependent
  • existing cardiopulmonary disease
  • Unstable medical situation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405558


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
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Principal Investigator: Claudio Perret Swiss Paraplegic Centre Nottwil
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03405558    
Other Study ID Numbers: 2017-01
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases