StrokeNCT06673940
TENS Effect on Gait and QoL in Stroke.
A study testing Transcutaneous electrical nerve stimulation (TENS) and Physical Therapy program in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) and Physical Therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 28 Oct 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of chronic stroke disease (6-8- months)
- Age 45-60 years old
- Mild to moderate spasticity
- Can walk 10 meters independently
- Sufficient cognitive abilities
Who cannot join
- Other neurological diseases
- Severe spasticity
- Cognitive impairments
- Medical instability
- Sever arthritis or contractures
- Cardio-pulmonary disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy Cairo University
Cairo, Giza Governorate, 12654
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Applied to Acupuncture Points on Gait and Quality of Life in Stroke Patients: a Randomized Controlled Study.
A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients.
Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. The outcome measures concerned with spasticity, gait and QoL.
Read the detailed description
A RCT study conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. The study was conducted at the outpatient clinic of Faculty of Physical Therapy, Cairo University and Kasr El-Ainy Hospitals, Faculty of Medicine, Cairo University, Egypt.
Forty subjects were screened for eligibility but only thirty stroke patients from both sexes aging from 40 to 65 years who were included and randomly assigned into two equal groups: study and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. Patients were treated three times weekly for four weeks.
The outcome measures included the Modified Ashworth Scale (MAS) for assessing spasticity, the WHOQOL-BREF scale for evaluating QoL and the Biodex Gait Trainer for measuring the gait kinematics. Evaluation of all variables took place pretreatment and post treatment.
- Conditions
- Stroke
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Physical Therapy program
- Keywords
- Stroke, spasticity, TENS, acupuncture points, gait, quality of life
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
TENS is applied on the acupuncture points Intervention arm
Physical Therapy programOther
Physical therapy methods
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | TENS applied to acupuncture points in addition to physical therapy program Receives: Device: Transcutaneous electrical nerve stimulation (TENS); Other: Physical Therapy program |
| control arm | Active comparator | only physical therapy program Receives: Other: Physical Therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth scale (MAS)
Spasticity assessment scale. Score (0-4) 0 means no increase in tone. 4 means rigidity The lower the score, the lower spasticity the patient has.
Measured: • "At baseline and at the end of treatment at 4 weeks"
World Health Organization quality of life instrument "WHOQOL-BREF"
Quality of life assessment questionnaire. A validated Arabic version was used. 26 items The scores on the scale from 1- 5 : 1 is the lowest score while 5 is the highest score. The higher score the participants get, the better QoL they have
Measured: • ""At baseline and at the end of treatment at 4 weeks""
Biodex Gait Trainer
A special treadmill to measure gait kinematic parameters
Measured: • ""At baseline and at the end of treatment at 4 weeks""
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Feb 2024
- Primary completion30 Aug 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amina Awad,PhD, Cairo University
- Investigators
- Maram A Mahmoud, MSc, Principal investigator, Cairo UniversityNahed A Salem, PhD, Study chair, Cairo UniversityEbtesam M Fahmy, PhD, Study chair, Cairo UniversityAmina M Awad, PhD, Study director, Cairo UniversityAsma A Salem, PhD, Study director, Faculty of Physical Therapy Suez UniversitySarah Heneidy, PhD, Study director, Cairo UniversityRania M Tawfik, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673940
- Sponsor's protocol ID
- P.TREC / 012 / 003990
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation Applied to Acupuncture Points on Gait and Quality of Life in Stroke Patients: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06673940
- Acronym / sponsor ID
- P.TREC / 012 / 003990
- Conditions
- Stroke
- Keywords
- Stroke, spasticity, TENS, acupuncture points, gait, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 5 Nov 2024 (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.
A study was conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients.
Thirty stroke patients from both sexes aging from 40 to 65 years were randomly assigned into two equal groups: study group and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. The outcome measures concerned with spasticity, gait and QoL.
Detailed description
A RCT study conducted to investigate the additional effect of TENS applied to acupuncture points to the physical therapy program on gait and quality of life in stroke patients. The study was conducted at the outpatient clinic of Faculty of Physical Therapy, Cairo University and Kasr El-Ainy Hospitals, Faculty of Medicine, Cairo University, Egypt.
Forty subjects were screened for eligibility but only thirty stroke patients from both sexes aging from 40 to 65 years who were included and randomly assigned into two equal groups: study and control group. The study group received TENS plus the designed physiotherapy program and the control group received only the same designed physiotherapy program. Patients were treated three times weekly for four weeks.
The outcome measures included the Modified Ashworth Scale (MAS) for assessing spasticity, the WHOQOL-BREF scale for evaluating QoL and the Biodex Gait Trainer for measuring the gait kinematics. Evaluation of all variables took place pretreatment and post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Device: Transcutaneous electrical nerve stimulation (TENS), Other: Physical Therapy programTENS applied to acupuncture points in addition to physical therapy program |
| control arm | Active comparator | Other: Physical Therapy programonly physical therapy program |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of chronic stroke disease (6-8- months)
- Age 45-60 years old
- Mild to moderate spasticity
- Can walk 10 meters independently
- Sufficient cognitive abilities
Key exclusion criteria (6 listed)
- Other neurological diseases
- Severe spasticity
- Cognitive impairments
- Medical instability
- Sever arthritis or contractures
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)TENS is applied on the acupuncture points Intervention arm | Device | Intervention arm |
| Physical Therapy programPhysical therapy methods | Other | Intervention arm, control arm |
Primary outcome
Modified Ashworth scale (MAS)
Time frame: • "At baseline and at the end of treatment at 4 weeks"
Spasticity assessment scale. Score (0-4) 0 means no increase in tone. 4 means rigidity The lower the score, the lower spasticity the patient has.
World Health Organization quality of life instrument "WHOQOL-BREF"
Time frame: • ""At baseline and at the end of treatment at 4 weeks""
Quality of life assessment questionnaire. A validated Arabic version was used. 26 items The scores on the scale from 1- 5 : 1 is the lowest score while 5 is the highest score. The higher score the participants get, the better QoL they have
Biodex Gait Trainer
Time frame: • ""At baseline and at the end of treatment at 4 weeks""
A special treadmill to measure gait kinematic parameters
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 5 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
Maram A Mahmoud, MSc principal investigator
Cairo University
Nahed A Salem, PhD study chair
Cairo University
Ebtesam M Fahmy, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) and Physical Therapy program in people with Stroke, run by Cairo University 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 5 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 5 Nov 2024. 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?
Modified Ashworth scale (MAS) (time frame: • "At baseline and at the end of treatment at 4 weeks"). The study lists 3 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 5 Nov 2024.