Condition category
Circulatory System
Date applied
07/11/2006
Date assigned
13/02/2007
Last edited
14/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernd Griewing

ORCID ID

Contact details

von Guttenbergstr.10
Bad Neustadt
97616
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

FOSSIL

Study hypothesis

Daily use of a shoulder joint function orthesis (Sporlastik) in shoulder joint subluxations after acute, ischaemic stroke can prevent the occurrence of a Shoulder-Hand-Syndrome (SHS) in comparison with a conservatively treated patient sample.

Ethics approval

Approval received from the local ethics committee (Ethikkommission Bayerische Landesärztekammer) on the 17th October 2006 (ref: 06072).

Study design

Two-armed, randomised, controlled, open trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ischaemic stroke with hemiparesis of the upper extremity and following shoulder joint subluxation

Intervention

Basic therapy for both groups, fitting of the shoulder joint function orthesis of the experimental group, and no additional measures for the control group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary terminating point:
The sum of SHS scores on the days 14, 21 and 28: x = SHS [d 14] + SHS [d 21] + SHS [d 28]

If a patient doesn’t have a follow-up value (after day seven), he will not be considered evaluable. In this case the recruiting for the replenishment of the drop number continues. Otherwise, the definition of the primary terminating point with missing values or potentially terminator point affecting supplementary therapies, the following rules apply:
Missing values, which no raised values follows, are replaced by the last raised value (rational one: with SHS, the score will rather rise as to sink, without SHS, in reverse).

This procedure is conservative: the therapeutic effect is thereby rather underestimated then overrated. If an additional therapy was necessary because of SHS, which potentially affects the SHS Score, then each raised value will be replaced by the last value noted before begin of the therapy, as long as the value is smaller than the last value before therapy (rational ones: without additional therapy the condition would have probably been not better than before the beginning of the therapy; another worsening during therapy, however is considered with this calculation).

Secondary outcome measures

Secondary terminating points:
Are the processes of the SHS score, of the muscle function, the anthropometry and the finger measurement over the four follow-up dates?

Furthermore, the processes of the SHS sub-scores as well as the categorical SHS evaluation will be analysed:
1. Zero to three: no SHS
2. Four to seven: uncertain
3. Eight to 14:SHS

More classifying of the SHS-Scores are formed, if this is put close by the distribution of the score values. Moreover, the data will be analysed in compliance with the four follow-up dates and telephone follow-ups. The entire compliance is formed by summarisation of the ordinal code values of the categories. Long-term terminator points are evaluated and judged by frequency and severances of the SHS symptomatology indicated by telephone follow-up.

Overall trial start date

21/11/2006

Overall trial end date

10/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Immediate ischaemic stroke with hemiparesis of the upper extremity (by Computed Tomography [CT] secured and proven) and following subluxation - immediate is defined within zero to 21 days after appearance
2. Hemiparesis of the upper extremity with a strength degree zero to three
3. Patient must be mobilised a minimum of four hours daily
4. Patients that have given their written consent
5. Patients of at least 18 years of age

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

1. Extreme neglect
2. Severe aphasia
3. Superpose or comatose patients
4. Patients with Passage syndrome
5. Patients that receive opioids and analogues
6. Disturbations in the areas of venous, lymphatic and arterial system within the localisation of the paretic arm, which contraindicates the fitting of the function or thesis
7. Planned or intended accompanied therapy:
a. physical therapy with depth-thermal treatment
b. additional therapy with thermal treatment (warmth/cooling)
8. Functional Electronic Stimulation (FES) of the hemiplegic’s shoulder
9. Contraindications of the producer:
a. allergic or inflammatory or injured conditioned skin changes (e.g. swelling, redness) of supplying body areas
b. circulation impairments or swelling of the soft, lymphatic tissues
c. neurogen caused disturbances of sensory and skintrophic symptoms in the supplying body region (feeling sensation is disturbed with or without skin damage)
10. Long lasting, continuous immobilisation, in particular with older people
11. Physical, psychological or mental inability to follow instructions

Recruitment start date

21/11/2006

Recruitment end date

10/06/2007

Locations

Countries of recruitment

Germany

Trial participating centre

von Guttenbergstr.10
Bad Neustadt
97616
Germany

Sponsor information

Organisation

Neurologische Klinik Bad Neustadt GmbH (Germany)

Sponsor details

von Guttenberg - Str.10
Bad Neustadt
97616
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Neurologische Klinik Bad Neustadt GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22308558

Publication citations

  1. Results

    Hartwig M, Gelbrich G, Griewing B, Functional orthosis in shoulder joint subluxation after ischaemic brain stroke to avoid post-hemiplegic shoulder-hand syndrome: a randomized clinical trial., Clin Rehabil, 2012, 26, 9, 807-816, doi: 10.1177/0269215511432355.

Additional files

Editorial Notes