An interventional study of Experimental Group and Control Group in Stroke, Multiple Sclerosis and Parkinson Disease, sponsored by IRCCS San Camillo, Venezia, Italy. Status unknown at 5 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by IRCCS San Camillo, Venezia, Italy · Not applicable, Interventional, and Treatment
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.
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.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.
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Common criteria:
Stroke:
Parkinson:
Multiple Sclerosis:
Exclusion Criteria:
In the EG the subjects will perform balance exercises using the OAK system under the supervision of a trained physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Device: Experimental Group
In the CG the subjects will be asked to perform conventional balance exercises under the supervision of a physiotherapist. The treatment will last 3 weeks with daily sessions of 60 minutes, 5 times per week.
Other: Control 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.
The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.
Berg Balance Scale (BBS)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 56).
Time frame: Change from baseline Berg Balance Scale at the end of the therapy (three weeks thereafter)
Number of falls during the last year
Applied at the beginning and at the end of treatment (after 15 sessions).
Time frame: Change from baseline number of falls during the last year scale at the end of the therapy (three weeks thereafter)
Functional Ambulation Classification (FAC)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 5).
Time frame: Change from baseline Functional Ambulation Classification at the end of the therapy (three weeks thereafter)
Activities specific-Balance Confidence scale (ABC)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).
Time frame: Change from baseline Activities specific-Balance Confidence scale at the end of the therapy (three weeks thereafter)
Functional Independence Measure (FIM)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 126).
Time frame: Change from baseline Functional Independence Measure at the end of the therapy (three weeks thereafter)
Barthel Index (BI)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means better outcome (minimum score = 0, maximum score = 100).
Time frame: Change from baseline Barthel Index at the end of the therapy (three weeks thereafter)
National Institution of Health Stroke Scale (NIHSS)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 42).
Time frame: Change from baseline National Institute of Health Stroke Scale at the end of the therapy (three weeks thereafter)
Unified Parkinson's Disease Rating Scale (UPDRS)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 147).
Time frame: Change from baseline Unified Parkinson's Disease Rating Scale at the end of the therapy (three weeks thereafter)
Hoehn & Yahr Scale (H&Y)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 5).
Time frame: Change from baseline Hoehn & Yahr Scale at the end of the therapy (three weeks thereafter)
Kurtzke Extended Disability Status Scale (EDSS)
Applied at the beginning and at the end of treatment (after 15 sessions). A higher score means worse outcome (minimum score = 0, maximum score = 10).
Time frame: Change from baseline Kurtzke Extended Disability Status Scale at the end of the therapy (three weeks thereafter)
Instrumental assessment
The OAK system will record the changes of the center of pressure during 30 seconds, with relaxed arms and eyes open.
Time frame: Change from baseline BBS at the end of the therapy (three weeks thereafter)
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IRCCS San Camillo, Venezia, Italy