Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury

Condition(s) studied

Investigational drug(s) / intervention(s)

Wearable device rehabilitation: Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.

Offline Traditional Rehabilitation: Offline Traditional Rehabilitation

Study summary

This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.

Eligibility

Primary outcome measure(s)

• Joint range of motion — Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
  Use a goniometer to measure the subject's shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation exercises to test the range of motion of the shoulder in each direction, with the unit in degrees (°).
• Upper Limb Closed-Chain Stability Test — Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
  For the starting position, male subjects perform a standard push-up, while female subjects perform a knee push-up, keeping their back flat. The distance between the hands is 36 inches. One hand remains in support while the other hand swings to touch the supporting hand and then returns to the starting position. Then switch the supporting hand and repeat the movement. One repetition is counted when the swinging hand leaves the ground, touches the supporting hand, and returns to the starting position. Record the number of full-effort hand touches completed by the subject within 15 seconds, and repeat the test 3 times.
• FMS Shoulder Mobility Test — Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
  The subjects were asked to make fists with both hands, placing their thumbs inside the fists. Then, the subjects were required to position one shoulder in maximum adduction, extension, and internal rotation, while the other shoulder was in maximum abduction, flexion, and external rotation, and both hands needed to be placed on the back in a smooth movement. Throughout the process, both hands remained clenched in fists. The tester measured the distance between the two closest bony prominences of the hands on the back. The test was repeated three times.
• Isometric Strength Test — Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
  The subjects performed shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation movements, resisting resistance to perform isometric contractions, and their muscle strength was measured.
• Surface electromyography — Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.
  Using the Delsys surface electromyography (EMG) test device to measure the surface EMG signals of shoulder muscles such as the anterior, middle, and posterior deltoid, serratus anterior, upper, middle, and lower trapezius, and supraspinatus during maximal voluntary contraction tests, with the unit of measurement being '%BW'.

Trial sites (1)

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