Robotic-assisted Training After Upper Arm Fracture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2019-12-01

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.

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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.

Conditions

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Shoulder Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intervention Armeo®Spring

Intervention Type 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.

Control group

The control group will receive conventional occupational- and physiotherapy.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

The control group will receive conventional occupational- and physiotherapy over 3 weeks

Interventions

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Intervention Armeo®Spring

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.

Intervention Type OTHER

Control Group

The control group will receive conventional occupational- and physiotherapy over 3 weeks

Intervention Type OTHER

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No