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

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.

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Key information

Conditions

Spinal Cord Injury, Acute Behavior Central Nervous System Diseases Motor Activity Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Acronym: MKraft_Erstr

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 16, 2018
Registry last updated: Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed