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Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury (MKraft_Erstr)

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: NCT03707704
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Study Description
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Brief Summary:

The aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015.

By default, the patients complete - depending on which training phase they are in - three to four strength training sessions per week. As part of the master's thesis, the development of maximum strength of patients with spinal cord injury (SCI) in primary rehabilitation will be studied. It is explicitly taken care of that the patients comply with the training requirements. Furthermore, factors which prevent a consistent buildup of strength - such as medical complications (pressure sores, pneumonia, urinary tract infections) - are systematically recorded.

The findings should provide information on the effect and qualitative transfer of the existing strength concept in everyday clinical practice. The strength training performed is accompanied by the master student and documented in a standardized manner.


Condition or disease
Spinal Cord Injury, Acute

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : November 30, 2019

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Groups and Cohorts
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Group/Cohort
SCI patients in primary rehabilitation


Outcome Measures
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Primary Outcome Measures :
  1. One-repetition-maximum as parameter for the maximum force [kg] [ Time Frame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks ]
    Calculated one-repetition-maximum based on the Brzycki equation formula


Secondary Outcome Measures :
  1. Number of completed training sessions (training compliance) [ Time Frame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks ]
    Number of completed training sessions per participant

  2. Causes of study exclusion [ Time Frame: From 0 weeks to 10 weeks ]
    Systematic documentation of exclusion causes during the participation in the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with acute spinal cord injury during their initial rehabilitation
Criteria

Inclusion Criteria:

  • Patients in initial rehabilitation
  • SCI Level C1-C5 (ASIA Score C-D)
  • SCI Lever C6-L5 (ASIA Score A-D)
  • Traumatic and non-traumatic SCI
  • Disease-related paraplegia, high-grade stenoses and central cord Syndromes
  • Age >= 18 years
  • The maximum force is tested on three predefined training devices, two devices for the upper and a device for the lower extremity. The participants will only be included in the study if they are capable of succeeding in at least both exercises for the upper extremity

Exclusion criteria:

  • Polyneuropathic diseases such as Critical Illness and Guillain Barré Syndrome
  • Degenerative diseases such as multiple sclerosis and amyotrophic lateral sclerosis etc.
  • Cognitive impairments
  • Compliance of less than 2/3 of the training sessions
  • ≥ 14 days without training
  • more than 6 weeks between assessments
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): NCT03707704


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03707704    
Other Study ID Numbers: 2018-16
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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
Keywords provided by Swiss Paraplegic Centre Nottwil:
Exercise
Rehabilitation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System