Robotic-assisted Training After Upper Arm Fracture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study

Conditions
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Shoulder Injury

Intervention / Treatment
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* Other: Intervention Armeo®Spring
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Armeo®Spring<br>The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks. | Other: Intervention Armeo®Spring<br>* 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.<br>|
| Active Comparator: Control group<br>The control group will receive conventional occupational- and physiotherapy. | Other: Control Group<br>* The control group will receive conventional occupational- and physiotherapy over 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic-assisted rehabilitation, humeral fracture, randomised controlled study