Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

NCT02628418 | Completed Results

• 1 other identifier: 1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Upper Extremity Hemiplegia; Disorder of Hand

Keywords

Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (4)

• Number of Patients Who Completed the Hand Rehabilitation Program

  Through study completion. The specific hand interventionn 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.

• 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.

• Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation

  Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction. The total upper extremity score involved adding one to the sum of the three actions. The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100.

  Baseline and end of the study after 30 sessions, an average of 6 weeks

• Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.

  Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.

  Baseline and end of the study after 30 sessions, an average of 6 weeks

Secondary Outcomes (5)

• The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)

  Baseline and end of the study after 30 sessions, an average of 6 weeks

• Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.

  Baseline and end of the study after 30 sessions, an average of 6 weeks

• Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.

  Baseline and end of the study after 30 sessions, an average of 6 weeks

• Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.

  Baseline and end of the study after 30 sessions, an average of 6 weeks

• The Costs Involved in Using Gloreha in the Rehabilitation

  Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.

Study Arms (2)

Gloreha Group

EXPERIMENTAL

The patients in the "Gloreha Group" underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation by Gloreha device

Other: General Rehabilitation; Device: Specific hand rehabilitation by Gloreha device

Control Group

OTHER

The patients in the Control Group underwent to following interventions: 1. General Rehabilitation 2. Specific hand rehabilitation performed by physiotherapist

Other: General Rehabilitation; Other: Specific hand rehabilitation performed by physiotherapist

Interventions

General Rehabilitation OTHER

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.

Control Group; Gloreha Group

Specific hand rehabilitation by Gloreha device DEVICE

Each training session consisted of six parts: 1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2. 7 min of a number sequence (counting from one to five); 3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4. A sequence of wave-like finger movements (7 min) 5. A sequence of fist opening/closing (7 min) 6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).

Gloreha Group

Specific hand rehabilitation performed by physiotherapist OTHER

The activities were: 1. Flexion-extension of the fingers (10 min); 2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min); 3. Adduction and abduction of the fingers (10 min); 4. 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).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Related Publications (1)

• Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.

  PMID: 27056250 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Palmira Bernocchi
• Organization: Fondazione Salvatore Maugeri

palmira.bernocchi@fsm.it

00390308253

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Care Continuity Unit, Fondazione Salvatore Maugeri, Institute of Lumezzane, (Brescia), Italy

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 15, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-08