Robotic-assisted Training After Upper Arm Fracture

Not Applicable

Completed

• Conditions: Shoulder Injury
• Interventions: Other: Control Group; Other: Intervention Armeo®Spring

• Registration Number: NCT03100201
• Lead Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH

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.

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Primary Completion: 2018-12-15
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	The control group will receive conventional occupational- and physiotherapy.
Intervention Armeo®Spring	Intervention Armeo®Spring	The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks.

Primary Outcome Measures

Name	Time	Method
Change in disability of the arm, shoulder and hand (DASH)	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	subjective questionnaire for assessing the disability of the arm, shoulder and hand

Secondary Outcome Measures

Name	Time	Method
Change in ROM	ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change	a goniometer-based measurement of the active range of motion (ROM) of the shoulder joint
Change in grip strength	grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change	measurement of the grip strength using the Jamar dynamometer
Change in the WMFT-O	WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change	WMFT-O is an objective test for assessing the disability of the shoulder

Trial Locations

Locations (3)

Robert-Bosch-Hospital; 🇩🇪 Stuttgart, Germany

Berufsgenossenschaftliche Klinik Murnau; 🇩🇪 Murnau am Staffelsee, Germany

Berufsgenossenschaftliche Klinik Ludwigshafen; 🇩🇪 Ludwigshafen, Germany