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 |
| Protocol serial number | N/A |
| Sponsor | Neurologische Klinik Bad Neustadt GmbH (Germany) |
| Funder | Neurologische Klinik Bad Neustadt GmbH (Germany) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
von Guttenbergstr.10
Bad Neustadt
97616
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-armed, randomised, controlled, open trial. |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Primary terminating point: |
| Key secondary outcome measure(s) |
Secondary terminating points: |
| Completion date | 10/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
97616
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |