HemiparesisNCT06997978
Efficacy of Tele-rehabilitation Intervention on Hand, Cognitive Functions & Depression of Hemiparetic Patients
A study testing Tele-rehabilitation and Hand rehabilitation program in people with Hemiparesis, run by Ahmed Alshimy at 1 site in Egypt.
Trial summary
Information and communication technologies (ICT) are used in telerehabilitation to deliver rehabilitation treatments to patients in their homes or other locations. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Tele-rehabilitation and Hand rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Information and communication technologies (ICT) are used in telerehabilitation to deliver rehabilitation treatments to patients in their homes or other locations.
Read the detailed description
Thirty hemiparetic patients with mild hand dysfunction of both sexes participated in the study (Age range was 45- to 55-year-old); 15 patients in the control group (GB) received a selected hand rehabilitation program, whereas 15 patients in the study group (GA) received telerehabilitation intervention. The 9HPT (Nine-hole peg test), FMUE (Fugl Meyer upper extremity), MOCA (Montreal cognitive assessment scale), REHACOM system, and the BECK DEPRESSION INVENTORY QUESTIONNAIRE were used to evaluate the patients in both groups before and after the treatment program began.
- Conditions
- Hemiparesis
- Being tested
- Tele-rehabilitation, Hand rehabilitation program
- Keywords
- Tele-rehabilitation, Hand functions, Cognitive functions, Depression, Hemiparesis
- Medical subject headings
- Paresis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Hand rehabilitation programOther
- Free exercises:
- Wrist flexion and extension 2. Wrist side movement 3. Thumb flexion and extension 4-Finger opposition 5. Palm up and down
- Ball exercises:
- Ball grip
- Finger flexion
- Thumb extend
- The pinch exercise
- Opposition 6- Side squeeze
- Extend out
- Household exercises
- Roll movement
- Wrist curl
- Extending the wrist
- Pen exercises
- Pinch and release
- Pen spine
- Exercises with coins
- Coin drop
- Coin stacking
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tele-rehabilitation; Other: 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. Receives: Other: Hand rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nine Hole Peg Test
Used to evaluate hemiparetic patients' finger dexterity
Measured: 12 weeks
Fugl Myer Upper extremities
Intended to assess the motor functioning and impairment of stroke patients
Measured: 12 weeks
Montreal Cognitive Assessment
Intended to identify moderate cognitive impairment and assess the various cognitive functions of stroke patients
Measured: 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
Measured: 12 weeks
Beck's Depression Inventory
a screening tool for depression and a means of determining the severity of depression
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Feb 2023
- Primary completion1 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Alshimy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Alshimy, AlRyada University for Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997978
- Sponsor's protocol ID
- P.T.REC/012/004309
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tele-rehabilitation Intervention on Hand, Cognitive Functions & Depression of Hemiparetic Patients
- ClinicalTrials.gov ID
- NCT06997978
- Acronym / sponsor ID
- P.T.REC/012/004309
- Conditions
- Hemiparesis
- Keywords
- Tele-rehabilitation, Hand functions, Cognitive functions, Depression, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmed AlshimyUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Information and communication technologies (ICT) are used in telerehabilitation to deliver rehabilitation treatments to patients in their homes or other locations.
Detailed description
Thirty hemiparetic patients with mild hand dysfunction of both sexes participated in the study (Age range was 45- to 55-year-old); 15 patients in the control group (GB) received a selected hand rehabilitation program, whereas 15 patients in the study group (GA) received telerehabilitation intervention. The 9HPT (Nine-hole peg test), FMUE (Fugl Meyer upper extremity), MOCA (Montreal cognitive assessment scale), REHACOM system, and the BECK DEPRESSION INVENTORY QUESTIONNAIRE were used to evaluate the patients in both groups before and after the treatment program began.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Tele-rehabilitation, Other: Hand rehabilitation programstudy 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. |
| Group B | Experimental | Other: Hand rehabilitation programcontrol 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-rehabilitationPatients 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. | Other | Group A |
| Hand rehabilitation program1. 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 | Other | Group A, Group B |
Primary outcome
The Nine Hole Peg Test
Time frame: 12 weeks
Used to evaluate hemiparetic patients' finger dexterity
Fugl Myer Upper extremities
Time frame: 12 weeks
Intended to assess the motor functioning and impairment of stroke patients
Montreal Cognitive Assessment
Time frame: 12 weeks
Intended to identify moderate cognitive impairment and assess the various cognitive functions of stroke patients
REHACOM system
Time frame: 12 weeks
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
Beck's Depression Inventory
Time frame: 12 weeks
a screening tool for depression and a means of determining the severity of depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis
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Recruiting
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation and Hand rehabilitation program in people with Hemiparesis, run by Ahmed Alshimy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nine Hole Peg Test (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.