Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury (MKraft_Erstr)
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ClinicalTrials.gov Identifier: NCT03707704 |
Recruitment Status :
Completed
First Posted : October 16, 2018
Last Update Posted : January 13, 2020
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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 |
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Spinal Cord Injury, Acute |
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 |

Group/Cohort |
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SCI patients in primary rehabilitation |
- 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
- 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

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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 |
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

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
Switzerland | |
Swiss Paraplegic Centre | |
Nottwil, Lucerne, Switzerland, 6207 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Exercise Rehabilitation |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |