NCT06520748

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 16, 2024

Last Update Submit

July 19, 2024

Conditions

Stroke

Keywords

StrokeHand recoveryPlasticityComputerized glove

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Study Group

EXPERIMENTAL

underwent a hand rehabilitation program using the computerized glove combined with the selected hand program

Other: Hand rehabilitation program using the computerized gloveOther: Selected hand program

Control Group

EXPERIMENTAL

received only the selected hand program

Other: Selected hand program

Interventions

Hand rehabilitation program using the computerized gloveOTHER

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

Study Group
Selected hand programOTHER

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.

Control GroupStudy Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Neurology and it's Surgery

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 25, 2024

Study Start

October 5, 2023

Primary Completion

February 6, 2024

Study Completion

April 3, 2024

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)