NCT07654582

Brief Summary

This study aims to investigate the effect of adding augmented cues to conventional physical therapy intervention on hand function in patients with post-stroke hemiparesis. Fifty patients with subacute ischemic stroke will be randomly assigned to either a study group receiving augmented cue-based training in addition to conventional physical therapy or a control group receiving conventional physical therapy alone. Hand function will be assessed before and after the intervention period using the Nine-Hole Peg Test (NHPT), hand grip strength measured by a dynamometer, and pressure pain threshold measured by a pressure algometer. The findings of this study may provide evidence regarding the effectiveness of augmented cue-based rehabilitation strategies in improving hand function after stroke.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Aug 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

augmented cuesstroke rehabhand functionmusical glovesupper extremity rehabilitiongrip strenght

Outcome Measures

Primary Outcomes (1)

  • Nine-Hole peg Test (NHPT)

    Manual dexterity assessed using the Nine-Hole Peg Test. The time required to place and remove nine pegs will be recorded in seconds. Lower scores indicate better hand dexterity.

    Baseline and after 8 weeks of treatment

Secondary Outcomes (2)

  • hand grip strength

    Baseline and after 8 weeks of treatment

  • pressure pain threshold

    Baseline and after 8 weeks of treatment

Study Arms (2)

control group

ACTIVE COMPARATOR

Participants will receive a conventional physical therapy program for hand rehabilitation after stroke. Treatment will be administered three times per week for eight weeks (24 sessions), with each session lasting 60 minutes and including range of motion exercises, strengthening exercises, stretching, and task-oriented hand training.

Other: Conventional physical therapy

musical gloves

EXPERIMENTAL

articipants will receive the same conventional physical therapy program provided to the control group in addition to MusicGlove training. Treatment will be administered three times per week for eight weeks (24 sessions). MusicGlove will provide augmented visual, auditory, and performance feedback during task-specific hand training.

Other: Conventional physical therapyDevice: musicgloves training

Interventions

Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke. The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training. Treatment will be provided three times per week for eight weeks (24 sessions).

control groupmusical gloves

MusicGlove is a sensor-based rehabilitation device that provides augmented visual, auditory, and performance feedback during task-specific hand exercises. Participants perform repetitive thumb-to-finger opposition and grasping movements synchronized with computer-based musical activities. Training will be provided in addition to conventional physical therapy three times per week for eight weeks.

musical gloves

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Male and female patients.
  • Age between 40 and 60 years.
  • First-ever subacute ischemic stroke.
  • Time since stroke between 6 weeks and 6 months.
  • Unilateral upper limb involvement.
  • Able to understand and follow verbal instructions.
  • Medically stable and able to participate in the rehabilitation program.
  • Willing to provide informed consent.

You may not qualify if:

  • \- Hemorrhagic stroke.
  • Bilateral stroke involvement.
  • Severe cognitive impairment or severe aphasia interfering with participation.
  • Severe visual or auditory deficits affecting training.
  • Severe upper limb spasticity that prevents hand training.
  • Other neurological disorders affecting upper limb function.
  • Severe musculoskeletal disorders of the upper limb.
  • Participation in another rehabilitation trial during the study period.
  • Unstable cardiovascular or medical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Moshera H Darwish, PHD

    Professor of Physical Therapy for Neurology and Neurosurgery Faculty of Physical Therapy Cairo University

    STUDY CHAIR
  • mariam m elsayed, phd

    Lecturer in department of physical Therapy for Neurology and Neurosurgery Faculty of physical therapy Cairo University

    STUDY DIRECTOR
  • Essam M Abdulwahab, PHD

    Professor of Neurology Faculty of Medicine Al-Azhar university

    STUDY DIRECTOR

Central Study Contacts

mariam mohamed elsayed, phd

CONTACT

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
Resident

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 17, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will be available from the corresponding author upon reasonable request.