Performance Developement of Patients With Paraplegia Duri... | NCT03405558

Studies
Performance Developement of Patients With Paraplegia During First Rehabilitation

NCT03405558

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Mar 13, 2023Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Physical Activity

Interventions

No intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 31, 2023Actual

Completion Date

Jan 31, 2023Actual

First Submitted Date

Jan 8, 2018

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2023

Last Update Posted Date

Mar 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak power	Maximal performance reached during incremental exercise on an arm-crank ergometer	10min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)
Age 18-65 years
Manual wheelchair user
Patient during first rehabilitation

Exclusion Criteria:

BMI ≥ 30
unable to use an arm-crank Ergometer due to e.g. spasticity
physical impairment, which makes it impossible to perform an arm-crank ergometry
Progressive disease (g.g. tumor, MS)
Ventilator dependent
existing cardiopulmonary disease
Unstable medical situation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects with a paraplegia during the first rehabilitation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudio Perret	Swiss Paraplegic Research, Nottwil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil	Canton of Lucerne	6207	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided