Underwater Electrical StimulationNCT07794189
Effect of Underwater Electrical Stimulation on Hand Grip Strength in Stroke Patients
A study testing 4-cell Hydrotherapy Bath in people with Underwater Electrical Stimulation, run by Deraya University at 1 site in Egypt.
Trial summary
This study evaluates the therapeutic effects of underwater electrical faradic stimulation delivered via a four-cell hydrotherapy bath on hand grip strength and upper limb motor recovery in subacute post-stroke hemiplegic patients. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Underwater Electrical Stimulation
- What is being tested?
- 4-cell Hydrotherapy Bath
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Jul 2026
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever ischemic or hemorrhagic stroke in the subacute phase (<6 months post-onset) confirmed by neuroimaging (CT or MRI).
- Chronological age ranging from 50 to 65 years.
- Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
Who cannot join
- Severe cognitive impairments or receptive language deficits precluding the ability to follow verbal instructions or communicate with research staff.
- Concurrent participation in other interventional clinical trials.
- Prior history of other neurological, severe musculoskeletal, or psychiatric disorders affecting upper limb function.
- Presence of skin lesions, open wounds, or severe peripheral vascular disease in the affected upper extremity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of physical therapy, Deraya University
Minya, Menia Governorate
About this study
Official title: Effects of Underwater Electrical Faradic Stimulation on Hand Grip Strength and Upper Extremity Motor Recovery in Sub-acute Post-Stroke Patients: A Double-Blinded, Randomized Placebo-Controlled Trial
This study evaluates the therapeutic effects of underwater electrical faradic stimulation delivered via a four-cell hydrotherapy bath on hand grip strength and upper limb motor recovery in subacute post-stroke hemiplegic patients.
Read the detailed description
Upper extremity motor impairment remains a major cause of persistent disability following subacute stroke. Forty-four participants with subacute post-stroke hemiparesis were recruited and randomized in a 1:1 ratio to either an experimental group or a placebo control group. Both groups received 12 treatment sessions across 4 consecutive weeks (3 sessions per week, 20 minutes per session). Group A received active underwater faradic current stimulation applied to the affected upper limb in a four-cell hydrotherapy bath. Group B underwent identical limb positioning and bath immersion with 0 mA current output. Hand grip strength (HGS) via Jamar dynamometry and motor function via the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) were assessed at baseline and post-intervention.
- Conditions
- Underwater Electrical Stimulation
- Being tested
- 4-cell Hydrotherapy Bath, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-cell Hydrotherapy BathOther
Underwater Faradic Stimulation: 4-cell hydrotherapy bath immersion for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Waveform: Faradic; Pulse Duration: 0-500 µs; Pulse Frequency: 20-50 Hz; Duty Cycle: 2.5s ON / 2.5s OFF; Peak Amplitude: Up to 100 mA (motor threshold).
PlaceboOther
Sham Hydrotherapy: Identical positioning and immersion in 4-cell hydrotherapy bath for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Device display active, output amplitude maintained at 0 mA.
| Study group | Role | What they receive |
|---|---|---|
| 4-cell Hydrotherapy Bath | Experimental | Underwater Faradic Stimulation: 4-cell hydrotherapy bath immersion for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Waveform: Faradic; Pulse Duration: 0-500 µs; Pulse Frequency: 20-50 Hz; Duty Cycle: 2.5s ON / 2.5s OFF; Peak Amplitude: Up to 100 mA (motor threshold). Receives: Other: 4-cell Hydrotherapy Bath |
| Placebo Control Group | Placebo comparator | Sham Hydrotherapy: Identical positioning and immersion in 4-cell hydrotherapy bath for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Device display active, output amplitude maintained at 0 mA. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength (HGS)
Measurement Tool: Jamar hydraulic hand dynamometer. Unit of Measure: Kilograms (kg). Description: Maximal voluntary contraction (MVC) measured following ASHT guidelines (average of three trials).
Measured: Baseline (T0) and Post-treatment at 4 weeks (T1)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Measurement Tool: FMA-UE Motor Subscale (33 items). Unit of Measure: Ordinal scale score (Range: 0 to 66 points). Description: Evaluates reflex activity, volitional movement, wrist stability, hand grasp, and coordination.
Measured: Baseline (T0) and Post-treatment at 4 weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underwater Electrical StimulationStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794189
- Sponsor's protocol ID
- PT-NEURO-2025-01
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Underwater Electrical Faradic Stimulation on Hand Grip Strength and Upper Extremity Motor Recovery in Sub-acute Post-Stroke Patients: A Double-Blinded, Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07794189
- Acronym / sponsor ID
- PT-NEURO-2025-01
- Conditions
- Underwater Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 31 Aug 2026 (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.
This study evaluates the therapeutic effects of underwater electrical faradic stimulation delivered via a four-cell hydrotherapy bath on hand grip strength and upper limb motor recovery in subacute post-stroke hemiplegic patients.
Detailed description
Upper extremity motor impairment remains a major cause of persistent disability following subacute stroke. Forty-four participants with subacute post-stroke hemiparesis were recruited and randomized in a 1:1 ratio to either an experimental group or a placebo control group. Both groups received 12 treatment sessions across 4 consecutive weeks (3 sessions per week, 20 minutes per session). Group A received active underwater faradic current stimulation applied to the affected upper limb in a four-cell hydrotherapy bath. Group B underwent identical limb positioning and bath immersion with 0 mA current output. Hand grip strength (HGS) via Jamar dynamometry and motor function via the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) were assessed at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-cell Hydrotherapy Bath | Experimental | Other: 4-cell Hydrotherapy BathUnderwater Faradic Stimulation: 4-cell hydrotherapy bath immersion for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Waveform: Faradic; Pulse Duration: 0-500 µs; Pulse Frequency: 20-50 Hz; Duty Cycle: 2.5s ON / 2.5s OFF; Peak Amplitude: Up to 100 mA (motor threshold). |
| Placebo Control Group | Placebo comparator | Other: PlaceboSham Hydrotherapy: Identical positioning and immersion in 4-cell hydrotherapy bath for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Device display active, output amplitude maintained at 0 mA. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-ever ischemic or hemorrhagic stroke in the subacute phase (<6 months post-onset) confirmed by neuroimaging (CT or MRI).
- Chronological age ranging from 50 to 65 years.
- Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
Key exclusion criteria (4 listed)
- Severe cognitive impairments or receptive language deficits precluding the ability to follow verbal instructions or communicate with research staff.
- Concurrent participation in other interventional clinical trials.
- Prior history of other neurological, severe musculoskeletal, or psychiatric disorders affecting upper limb function.
- Presence of skin lesions, open wounds, or severe peripheral vascular disease in the affected upper extremity.
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 |
|---|---|---|
| 4-cell Hydrotherapy BathUnderwater Faradic Stimulation: 4-cell hydrotherapy bath immersion for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Waveform: Faradic; Pulse Duration: 0-500 µs; Pulse Frequency: 20-50 Hz; Duty Cycle: 2.5s ON / 2.5s OFF; Peak Amplitude: Up to 100 mA (motor threshold). | Other | 4-cell Hydrotherapy Bath |
| PlaceboSham Hydrotherapy: Identical positioning and immersion in 4-cell hydrotherapy bath for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Device display active, output amplitude maintained at 0 mA. | Other | Placebo Control Group |
Primary outcome
Hand Grip Strength (HGS)
Time frame: Baseline (T0) and Post-treatment at 4 weeks (T1)
Measurement Tool: Jamar hydraulic hand dynamometer. Unit of Measure: Kilograms (kg). Description: Maximal voluntary contraction (MVC) measured following ASHT guidelines (average of three trials).
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: Baseline (T0) and Post-treatment at 4 weeks (T1)
Measurement Tool: FMA-UE Motor Subscale (33 items). Unit of Measure: Ordinal scale score (Range: 0 to 66 points). Description: Evaluates reflex activity, volitional movement, wrist stability, hand grasp, and coordination.
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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 4-cell Hydrotherapy Bath in people with Underwater Electrical Stimulation, run by Deraya 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 3 inclusion and 4 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 2 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
Hand Grip Strength (HGS) (time frame: Baseline (T0) and Post-treatment at 4 weeks (T1)). The study lists 2 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 2 Sep 2026.