NCT03441009

Brief Summary

Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre. Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

4.8 years

First QC Date

February 9, 2018

Last Update Submit

September 18, 2021

Conditions

Autonomic Nervous System Imbalance

Keywords

PSH, Rehabilitation, Medication, ANS

Outcome Measures

Primary Outcomes (2)

  • Difference before vs after intervention in frequency domain parameters of HRV

    HRV parameters: low frequency (LF, 0.04-0.15 Hz), high frequency (HF, 0.15-0.4 Hz) in terms of peak frequency (Hz), absolute power (ms2, natural logarithm transformed values of absolute powers of VLF, LF, and HF bands), relative power (absolute power/total power), normalized power (%, normalized units, n.u.), total power given by VLF + HF + LF (ms2) and LF/HF ratio.

    immediate

  • Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions

    Two independent ratings on a 5-point scale, -2 to +2

    immediate

Interventions

Physio-/occupational therapyOTHER

Physio-/occupational therapy, ADL

Also known as: Psycotropic medications

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation

You may qualify if:

  • Symptoms of PSH according to Baguley scoring table

You may not qualify if:

  • No symptoms of PSH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jørgen Feldbæk, Professor

    Hammel Neuro- and Research Centre

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 22, 2018

Study Start

January 2, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share