Effectiveness of the use of a shoulder joint function orthesis" in shoulder joint subluxation after ischaemic brain stroke to avoid post hemiplegics shoulder-hand syndrome

ISRCTN	ISRCTN61157551
DOI	https://doi.org/10.1186/ISRCTN61157551
Secondary identifying numbers	N/A

Submission date: 07/11/2006
Registration date: 13/02/2007
Last edited: 14/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bernd Griewing
Scientific

von Guttenbergstr.10
Bad Neustadt
97616
Germany

Study information

Study design	Two-armed, randomised, controlled, open trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	FOSSIL
Study objectives	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(s)	Approval received from the local ethics committee (Ethikkommission Bayerische Landesärztekammer) on the 17th October 2006 (ref: 06072).
Health condition(s) or problem(s) studied	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
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 study start date	21/11/2006
Completion date	10/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	50
Key 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
Key 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
Date of first enrolment	21/11/2006
Date of final enrolment	10/06/2007

Locations

Countries of recruitment

Germany

Study participating centre

von Guttenbergstr.10

Bad Neustadt
97616
Germany

Sponsor information

Neurologische Klinik Bad Neustadt GmbH (Germany)
Government

von Guttenberg - Str.10
Bad Neustadt
97616
Germany

Funders

Funder type

Government

Neurologische Klinik Bad Neustadt GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2012		Yes	No

Effectiveness of the use of a shoulder joint function orthesis" in shoulder joint subluxation after ischaemic brain stroke to avoid post hemiplegics shoulder-hand syndrome