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Completed

NCT Number: NCT06520748

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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
  • Duration of illness ranges from (6weeks to 6 months) after stroke onset.
  • first stroke.
  • Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
  • 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

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

Treatment and study plan

Hand rehabilitation program using the computerized glove

Other

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

Selected hand program

Other

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.

Primary outcomes

  1. Quantitive Electro Encephalo Graphy

    Time frame: 6 weeks

    Used to assess Neuralplasticity (sleep Delta - Delta/Beta ratio )

  2. Computerized glove software

    Time frame: 6 weeks

    Used to assess the Kinematic Data (Thumb, Index, Middle, ring, little, and average range of motion)

  3. Action Research Arm Test

    Time frame: 6 weeks

    Used to assess Fine manual dexterity

Sponsors and collaborators

Lead sponsor

Ahmed Alshimy

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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