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

Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury, Acute

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Switzerland
  • Lucerne
    • Nottwil, Lucerne, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with acute spinal cord injury during their initial rehabilitation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SCI patients in primary rehabilitation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of completed training sessions (training compliance)	Number of completed training sessions per participant	Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Causes of study exclusion	Systematic documentation of exclusion causes during the participation in the study	From 0 weeks to 10 weeks

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2018-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No