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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61157551

Enrollment

Registered

2007-02-13

Start date

2006-11-21

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026