Clinical trial NCT03707704: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury, Acute
Keywords: Exercise
Rehabilitation
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2018-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with acute spinal cord injury during their initial rehabilitation

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.


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

Primary outcomes:
measure: One-repetition-maximum as parameter for the maximum force [kg]
timeFrame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Secondary outcomes:
measure: Number of completed training sessions (training compliance)
timeFrame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
measure: Causes of study exclusion
timeFrame: From 0 weeks to 10 weeks
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
References: