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Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

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ClinicalTrials.gov Identifier: NCT02628418
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : August 3, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Palmira Bernocchi, Fondazione Salvatore Maugeri

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stroke
Upper Extremity Hemiplegia
Disorder of Hand
Interventions: Other: General Rehabilitation
Device: Specific hand rehabilitation by Gloreha device
Other: Specific hand rehabilitation performed by physiotherapist

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gloreha Group

The patients in the "Gloreha Group" underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.

SHR by Gloreha 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).

Control Group

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.

SHR performed by physiotherapist: 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).

Participant Flow:   Overall Study
    Gloreha Group   Control Group
STARTED   15   15 
COMPLETED   14   13 
NOT COMPLETED   1   2 
Lost to Follow-up                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gloreha Group

The patients in the "Gloreha Group" underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific Hand Rehabilitation (SHR) by Gloreha device

GR: 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.

SHR by Gloreha 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).
Control Group

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation
  2. Specific Hand Rehabilitation (SHR) performed by physiotherapist

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.

SHR performed by physiotherapist: 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).
Total Total of all reporting groups

Baseline Measures
   Gloreha Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 72  (11)   73  (14)   72.5  (12.5) 
Gender 
[Units: Participants]
     
Female   8   8   16 
Male   7   7   14 


  Outcome Measures

1.  Primary:   Number of Patients Who Completed the Hand Rehabilitation Program   [ Time Frame: 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. ]

2.  Primary:   Side Effects Using Gloreha Device   [ Time Frame: 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. ]

3.  Primary:   Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

4.  Primary:   Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

5.  Secondary:   The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

6.  Secondary:   Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

7.  Secondary:   Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

8.  Secondary:   Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.   [ Time Frame: Baseline and end of the study after 30 sessions, an average of 6 weeks ]

9.  Secondary:   The Costs Involved in Using Gloreha in the Rehabilitation   [ Time Frame: Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Palmira Bernocchi
Organization: Fondazione Salvatore Maugeri
phone: 00390308253 ext 260
e-mail: palmira.bernocchi@fsm.it


Publications of Results:

Responsible Party: Palmira Bernocchi, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT02628418     History of Changes
Other Study ID Numbers: 1
First Submitted: December 3, 2015
First Posted: December 11, 2015
Results First Submitted: February 5, 2016
Results First Posted: August 3, 2016
Last Update Posted: September 15, 2016