Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Stroke Clinical Trial

Official title:

Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation in Hemiplegic Stroke Patients: a Randomized Pilot Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628418
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: December 3, 2015
• Last updated: December 11, 2015
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.

Description:

Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.

Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.

In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.

Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred = 30 days before, with Ashworth spasticity index < 3.

Exclusion Criteria:

• orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);

• peripheral nerve injury;

• uncontrolled inflammation;

• severe cognitive and behavioral disorders;

• neurodegenerative and neuromuscular diseases;

• Ashworth spasticity index = 3.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Hand
• Hemiplegia
• Stroke
• Upper Extremity Hemiplegia

Intervention

Other:
• General Rehabilitation
All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.

Device:
• Specific hand rehabilitation by Gloreha device
Each training session consisted of six parts: A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 7 min of a number sequence (counting from one to five); A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) A sequence of wave-like finger movements (7 min) A sequence of fist opening/closing (7 min) A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).

Other:
• Specific hand rehabilitation performed by physiotherapist
The activities were: Flexion-extension of the fingers (10 min); Thumb opposition with the other fingers keeping the forearm in supine position (10 min); Adduction and abduction of the fingers (10 min); Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who completed the hand rehabilitation program using a new neuromotor rehabilitation device (Gloreha)		Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.	No
Primary	Side effects using Gloreha device	The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);	Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.	Yes
Primary	Efficacy in improving arm function abilities measured by Motricity Index	Motricity Index, a measure of the motor function of the paretic upper limb.	Change from baseline Motricity Index at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks)	No
Primary	Efficacy in improving arm function abilities measured by Nine Hole Peg Test	Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity.	Change from baseline Motricity Index at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks)	No
Secondary	The feasibility of this new neuromotor rehabilitation device (Gloreha)	The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult).	Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.	No
Secondary	Efficacy in improving arm function abilities measured by the Grip test	The Grip Pinch test, a measure of strength. For each evaluation, the mean value of 3 tests normalized for body mass index (BMI) was calculated.	Change from baseline Grip test at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks)	No
Secondary	Efficacy in improving arm function abilities measured by the Pinch test	The Pinch test, a measure of strength. For each evaluation, the mean value of 3 tests normalized for body mass index (BMI) was calculated.	Change from baseline Pinch test at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks)	No
Secondary	Efficacy in improving arm function abilities measured by the Quick-DASH questionnaire	The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.	Change from baseline Quick-DASH at the end of the inpatient rehabilitation (through study completion, after 30 sessions and an average of 6 weeks)	No
Secondary	The costs involved in using Gloreha in the rehabilitation	Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.	Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.	No