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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

Tracking Information
First Submitted Date October 11, 2018
First Posted Date October 16, 2018
Last Update Posted Date January 13, 2020
Actual Study Start Date October 10, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2018)
  • 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
  • Causes of study exclusion [ Time Frame: From 0 weeks to 10 weeks ]
    Systematic documentation of exclusion causes during the participation in the study
Original Secondary Outcome Measures
 (submitted: October 11, 2018)
  • 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
  • Study exclusion [ Time Frame: From 0 weeks to 10 weeks ]
    Systematic documentation of exclusion causes during the participation in the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury
Official Title Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects with acute spinal cord injury during their initial rehabilitation
Condition Spinal Cord Injury, Acute
Intervention Not Provided
Study Groups/Cohorts SCI patients in primary rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2020)
20
Original Estimated Enrollment
 (submitted: October 11, 2018)
25
Actual Study Completion Date November 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03707704
Other Study ID Numbers 2018-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Swiss Paraplegic Centre Nottwil
Study Sponsor Swiss Paraplegic Centre Nottwil
Collaborators Not Provided
Investigators Not Provided
PRS Account Swiss Paraplegic Centre Nottwil
Verification Date January 2020