IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN STROKE

IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN PATIENT WITH STROKE

Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Hand rehabilitation program using the computerized glove; Other: Selected hand program

Detailed Description

Thirty male/female stroke patients in the sub-acute phase were randomly assigned in to the two groups (study and control) in sets of three. The study group (A) (n = 15) underwent a hand rehabilitation program using the computerized glove combined with the selected hand program. The control group (B) (n = 15) received only the selected hand program. The treatment schedules for 18 consecutive treatment sessions, three times per week.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Sadat, Menoufia, Egypt
      • Al Ryada University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
2. Duration of illness ranges from (6weeks to 6 months) after stroke onset.
3. first stroke.
4. Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
5. With a minimum 10° extension and/or flexion of the wrist or fingers, an ability to flex and extend the wrist joint five times continuously without losing active range of motion.

Exclusion Criteria: Patients with the following

1. apraxia or hemianopsia.
2. diabetic polyneuropathy.
3. Aphasia , cognitive deficits.
4. a previous disability in the upper limbs, tactile agnosia (stereognosis).
5. LT hemiplegia, Post Botox injection, recurrent stroke, and Posterior parietal lesion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; underwent a hand rehabilitation program using the computerized glove combined with the selected hand program	Other: Hand rehabilitation program using the computerized glove; The patient extended finger to reach from grey to green to red colour and heard the beep providing knowledge of result (KR), whereas the increase of range of finger extension reached every session provides knowledge of performance (KP). As the patient's performance improved, the range of their finger's movement will also be increased due to the augmented feedback provided to the patient and the therapist through the glove software; Other: Selected hand program; Distal key point of Bobath, approximation of affected arm, to control spasticity of wrist/ finger flexor (5 minutes). Dynamic splint to facilitate wrist and finger extension (10 repeat*5 sets). Passive range of motion exercise (10 repeat*5 sets) for each joint. Mud exercise (spherical, clyndrical , hook). Thera band exercises.
Experimental: Control Group; received only the selected hand program	Other: Selected hand program; Distal key point of Bobath, approximation of affected arm, to control spasticity of wrist/ finger flexor (5 minutes). Dynamic splint to facilitate wrist and finger extension (10 repeat*5 sets). Passive range of motion exercise (10 repeat*5 sets) for each joint. Mud exercise (spherical, clyndrical , hook). Thera band exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitive Electro Encephalo Graphy	Used to assess Neuralplasticity (sleep Delta - Delta/Beta ratio )	6 weeks
Computerized glove software	Used to assess the Kinematic Data (Thumb, Index, Middle, ring, little, and average range of motion)	6 weeks
Action Research Arm Test	Used to assess Fine manual dexterity	6 weeks

Collaborators and Investigators

• Sponsor: Ahmed Alshimy

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): February 6, 2024
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Plasticity; Hand recovery; Computerized glove
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: P.T.REC/012/004602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No