Clinical trial NCT03100201: Robotic-assisted Training After Upper Arm Fracture
Official title: Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injury
Keywords: robotic-assisted rehabilitation
humeral fracture
randomised controlled study
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
Collaborators: name: BG Unfallklinik Murnau
name: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
name: Deutsche Gesetzliche Unfallversicherung (DGUV)
First posted: 2017-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
* movement-stable fracture
* Inclusion between the fourth and the seventh week after surgery

Exclusion Criteria:

* limited cognition as defined by a score in Short-Orientation-Memory-Concentration Test (SOMC) less than 10 points
* inadequate level of pain during movement of the affected shoulder joint (pain score \>5 on a visual analogue pain scale)
* strongly limited vision or hearing
* heart failure (New York Heart Association stage III-IV) or COPD (Chronic Obstructive Pulmonary Disease) Gold stage III-IV
* walking speed \<0.8m/sec
* isolated tuberculum majus fracture of the humerus (AO 11, A1)
* fractures with involvement of the glenoid cavity
* double fractures
* injury of the plexus or the axillaris nerve

Primary outcomes:
measure: Change in disability of the arm, shoulder and hand (DASH)
timeFrame: 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
Secondary outcomes:
measure: Change in the WMFT-O
timeFrame: WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
measure: Change in ROM
timeFrame: ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
measure: Change in grip strength
timeFrame: grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Berufsgenossenschaftliche Klinik Ludwigshafen
city: Murnau am Staffelsee
country: Germany
facility: Berufsgenossenschaftliche Klinik Murnau
city: Stuttgart
country: Germany
facility: Robert-Bosch-Hospital
Study officials:
affiliation: BG Unfallklinik Murnau
name: Peter Augat, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.