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

Spinal Cord Injury, Acute Clinical Trial

— MKraft_Erstr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707704
• Other study ID #: 2018-16
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: January 2020
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury, Acute

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Causes of study exclusion	Systematic documentation of exclusion causes during the participation in the study	From 0 weeks to 10 weeks