Robotic-assisted Training After Upper Arm Fracture (RASTA)

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Status: Completed

Conditions: Shoulder Injury

Treatments: Other: Control Group; Other: Intervention Armeo®Spring

Study type: Interventional

Funder types: Other

Identifiers

NCT03100201

RASTA 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Intervention Armeo®Spring

Active Comparator group

Description:

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

Treatment:

Other: Intervention Armeo®Spring

Control group

Active Comparator group

Description:

The control group will receive conventional occupational- and physiotherapy.

Treatment:

Other: Control Group