NCT06997978

Brief Summary

Information and communication technologies (ICT) are used in telerehabilitation to deliver rehabilitation treatments to patients in their homes or other locations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

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

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

May 22, 2025

Last Update Submit

May 22, 2025

Conditions

Hemiparesis

Keywords

Tele-rehabilitationHand functionsCognitive functionsDepressionHemiparesis

Outcome Measures

Primary Outcomes (5)

  • The Nine Hole Peg Test

    Used to evaluate hemiparetic patients' finger dexterity

    12 weeks

  • Fugl Myer Upper extremities

    Intended to assess the motor functioning and impairment of stroke patients

    12 weeks

  • Montreal Cognitive Assessment

    Intended to identify moderate cognitive impairment and assess the various cognitive functions of stroke patients

    12 weeks

  • REHACOM system

    a software program made for diagnosing and treating patients with cognitive impairments. Figural memory (FM), attention concentration (AC), reaction behavior (RB), and logical reasoning (LR) are their four categories

    12 weeks

  • Beck's Depression Inventory

    a screening tool for depression and a means of determining the severity of depression

    12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

study group A (n = 15) received the hand rehabilitation program through the Tele-rehabilitation program, a technological device. The rehabilitation was three times a week for a total of twelve weeks (36 sessions) following the conclusion of the rehabilitation program.

Other: Tele-rehabilitationOther: Hand rehabilitation program

Group B

EXPERIMENTAL

control group B (n = 15) received the same hand rehabilitation program at the physical therapy clinic. The rehabilitation was three times a week for a total of twelve weeks (36 sessions) following the conclusion of the rehabilitation program.

Other: Hand rehabilitation program

Interventions

Tele-rehabilitationOTHER

Patients at the Telerehabilitation group are contacted via laptops that have cameras, microphones, and a reliable internet connection. The therapist's laptop camera is positioned so the patient may watch the therapist while the therapist demonstrates the exercises. After the therapist performs the exercise on himself, the patient must see the therapist via a laptop camera and then perform the same activity again.

Group A
Hand rehabilitation programOTHER

1. Free exercises: 1\. Wrist flexion and extension 2. Wrist side movement 3. Thumb flexion and extension 4-Finger opposition 5. Palm up and down 2. Ball exercises: 1. Ball grip 2. Finger flexion 3. Thumb extend 4. The pinch exercise 5. Opposition 6- Side squeeze 7\. Extend out 3. Household exercises 1. Roll movement 2. Wrist curl 3. Extending the wrist 4. Pen exercises 1. Pinch and release 2. Pen spine 5. Exercises with coins 1. Coin drop 2. Coin stacking

Group AGroup B

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between the ages of 45 and 55 were included in this study.
  • Both men and women were among the patients. Patients with duration of illness between three to six months.
  • According to the modified Ashworth scale (MAS), the patients' hand spasticity ranged from grade 1 to +1.
  • The patients had a Fugl Myer upper extremity score of at least nine, indicating mild hand function. On the BECK DEPRESSION INVENTORY questionnaire, the patients' score ranged from 17 to 20 (Borderline clinical depression). Every patient had good vision and hearing.
  • The patients successfully filled out the consent form and completed the assigned activities.
  • In order to enable video communication while at home, patients need to have at least ten years of education to be able to use a smart device that is connected to the internet, such as a laptop, phone, or tablet.
  • In addition to medical care, the patients shouldn't receive any other kind of treatment.
  • The patients should be able to communicate and obey commands with ease. - - The patients' MMSE scores were over 21, indicating good cognitive abilities.

You may not qualify if:

  • Individuals with unstable medical conditions, such as unstable angina, symptomatic heart failure, or uncontrolled diabetes mellitus or hypertension. - --- Patients who are unable to utilize the video communication device, have moderate to severe impairment of hand functions, or have any other pathology impacting hand function except stroke.
  • Patients who have visual or hearing impairments.
  • Patients who have communication issues or who have trouble understanding or obeying instructions.
  • Individuals who have seizures or psychological disorders.
  • Patients who have not had a stroke but have another illness that impairs cognitive function.
  • Individuals who have a history of stroke or other neurological conditions.

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

ParesisDepression

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Physical Therapy

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

February 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 20, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)