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

NCT03707704 | Completed DMC

• 1 other identifier: 2018-16
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury, Acute

Keywords

Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of completed training sessions (training compliance)

  Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks

• Causes of study exclusion

  From 0 weeks to 10 weeks

Study Arms (1)

SCI patients in primary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with acute spinal cord injury during their initial rehabilitation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: October 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: November 30, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)