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| Name | Class |
|---|---|
| BG Unfallklinik Murnau | OTHER |
| Berufsgenossenschaftliche Unfallklinik Ludwigshafen | OTHER |
| Deutsche Gesetzliche Unfallversicherung (DGUV) | UNKNOWN |
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In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.
60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Armeo®Spring | Active Comparator | The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks. |
|
| Control group | Active Comparator | The control group will receive conventional occupational- and physiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Armeo®Spring | Other | The robotic-assisted training will be performed using the clinically evaluated Armeo®Spring medical device (Hocoma AG, Zurich, Switzerland). By means of a sensory orthosis, arm movements will be supported and transmitted to a computer system and visually shown on a screen. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disability of the arm, shoulder and hand (DASH) | subjective questionnaire for assessing the disability of the arm, shoulder and hand | DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the WMFT-O | WMFT-O is an objective test for assessing the disability of the shoulder | WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change |
| Change in ROM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Augat, Prof. | BG Unfallklinik Murnau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berufsgenossenschaftliche Klinik Ludwigshafen | Ludwigshafen | 67071 | Germany | |||
| Berufsgenossenschaftliche Klinik Murnau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. | |
| 31279331 | Derived | Nerz C, Schwickert L, Scholch S, Gordt K, Nolte PC, Kroger I, Augat P, Becker C. Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures. BMC Musculoskelet Disord. 2019 Jul 6;20(1):315. doi: 10.1186/s12891-019-2691-0. |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001134 | Arm Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Patients will be recruited in three different clinics in Germany and randomised into an intervention and a control group. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
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| Control Group | Other | The control group will receive conventional occupational- and physiotherapy over 3 weeks |
|
a goniometer-based measurement of the active range of motion (ROM) of the shoulder joint
| ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change |
| Change in grip strength | measurement of the grip strength using the Jamar dynamometer | grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change |
| Murnau am Staffelsee |
| 82418 |
| Germany |
| Robert-Bosch-Hospital | Stuttgart | 70376 | Germany |
| 29212528 | Derived | Nerz C, Schwickert L, Becker C, Studier-Fischer S, Mussig JA, Augat P. Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial. Trials. 2017 Dec 6;18(1):589. doi: 10.1186/s13063-017-2274-z. |
| D008722 | Methods |