Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: A-ROM Continuous Passive Rehabilitation; Device: P-ROM Continuous Passive Rehabilitation

• Registration Number: NCT01936298
• Lead Sponsor: Chiara Mulé

Brief Summary

The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

Detailed Description

We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.

We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-06
• Status Verified: 2013-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• a history of acute phase of stroke (less than 12 months post onset),
• first stroke episode,
• no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
• no contracture of the affected wrist or fingers (Modified Ashworth<3),
• no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
• for P-ROM patients, the absence of active hand movements,
• for the A-ROM patients, the presence of active hand movements.

Exclusion Criteria

• unstable medical disorders,
• active Complex Regional Pain Syndrome (CRPS),
• severe spatial neglect,
• aphasia,
• cognitive problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-ROM Continuous Passive Rehabilitation	A-ROM Continuous Passive Rehabilitation	The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.
P-ROM Continuous Passive Rehabilitation	P-ROM Continuous Passive Rehabilitation	The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy.

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Perimeter edema	1 day after the treatment

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of Visual analogue scale (VAS)	1 day after the treatment
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)	1 day after the treatment
Change from Baseline of Range Of Motion (ROM)	1 day after the treatment
Clinical Global Impression (CGI)	1 day after the treatment

Trial Locations

Locations (1)

Habilita, Ospedale di Sarnico; 🇮🇹 Sarnico, Bergamo, Italy