NCT04874051

Sensor-based Assessment and Rehabilitation of Balance in Neurological Diseases

Sensor-Based Analysis And rehabiLitation of bAlance in Neurological Diseases: a multiCentric randomizEd Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: IRCCS San Camillo, Venezia, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Balance impairment is one of the most common disorders due to a neurological diseases. Sensor-based technologies may be useful for falls prevention and balance recovery during patients hospitalization. OAK Elderly Care System (Khymeia Group, Noventa Padovana, Italy) allows the assessment of fall risk, the centre of pressure and the execution of balance exercises in a virtual environment.

Detailed description

The aim of the study is to compare the therapy provided by means of the OAK Elderly Care System with conventional physiotherapy for balance rehabilitation in patients affected by stroke, Multiple Sclerosis (MS) and Parkinson Disease (PD). OAK Elderly Care System consists of two independent balance boards and three sensors for the kinematic tracking of the trunk and lower limbs. These components allow the assessment of the centre of pressure and the execution of exercises in a virtual environment. 120 patients (40 stroke, 40 MS, 40 PK) hospitalized at 4 different italian hospitals, were enrolled according to inclusion and exclusion criteria and randomly assigned to two groups (i.e. intervention group, control group). Intervention group received 1 daily hour of technology-based treatment, while the control group underwent 1 daily hour of physiotherapy for balance rehabilitation, in addiction to 1 hour of conventional physiotherapy. Both treatments lasted 15 sessions. Before and after treatment balance, walking, daily living autonomy and pathology-specific features were assessed.

Conditions

• Stroke
• Multiple Sclerosis
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Experimental Group	The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.
OTHER	Control Group	The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.

Timeline

• Start date: 2019-09-02
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-05-05
• Last updated: 2023-03-22

Locations

5 sites across 1 country: Italy