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 measure
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 doesnt 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 (if study stopped)
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 hemiplegics 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
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22308558
Publication citations
-
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.