HemiplegiaNCT06965894
Lower Extremity Pressure Splints in HP
A study testing Johnston Pressure Splint and Rehabilitation Program in people with Hemiplegia and Lower Extremity Dysfunction, run by Istinye University at 1 site in Lebanon.
Trial summary
Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hemiplegia, Lower Extremity Dysfunction, Stroke Rehabilitation
- What is being tested?
- Johnston Pressure Splint and Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 13 May 2025to 25 Nov 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having hemiplegia because of stroke
- Time since stroke: 1 month to 1 year
- Ability to Participate (a score of >24 on the Mini-Mental State Examination).
- Being voluntary
- Age between 40-80
Who cannot join
- Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pressure Splints on Lower Extremity Functions in Hemiplegic Stroke Patients
Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke and suffer from hemiplegia. Pressure splints are specialized devices designed to support and enhance muscle function by applying gentle pressure to the affected limbs.
Participants in this study will be randomly assigned to one of two groups: the Splint Group (SG) or the Control Group (CG). The duration of the intervention will be six weeks. During this period, all the participants will receive neurodevelopmental therapy. In the SG exercises will be done with the help of the lower extremity pressure splints while participants in the CG will join the exercises without any splint.
This study is significant as it may lead to the development of new methods to enhance recovery for stroke patients and offer better rehabilitation options.
- Being tested
- Johnston Pressure Splint, Rehabilitation Program
- Keywords
- Stroke, Rehabilitation, Gait, Johnstone Splint, Motor Recovery
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Johnston Pressure SplintDevice
Application of a Johnston pressure splint to the lower extremity.
Rehabilitation ProgramOther
Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.
| Study group | Role | What they receive |
|---|---|---|
| Splint Group | Experimental | Participants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques. In addition to the rehabilitation program, a Johnston pressure splint will be applied to the affected lower extremity during therapy sessions. The intervention aims to provide controlled pressure and support to improve motor recovery, balance, and gait in hemiplegic stroke patients. Receives: Device: Johnston Pressure Splint; Other: Rehabilitation Program |
| Control Group | Active comparator | Participants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques without the pressure splint. This group will serve to compare the effects of standard rehabilitation alone versus rehabilitation combined with pressure splinting. Receives: Other: Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Motor Function
The improvement in motor function of the lower extremity will be assessed by Fugl-Meyer Assessment for Lower Extremity (FMA). The FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 34.
Measured: Through study completion, an average of 8 months
Balance
The Berg Balance Scale (BBS) will be used to assess balance. This scale objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: Through study completion, an average of 8 months
Lower Extremity Strength
The Five Times Sit to Stand Test will be used for the assessment of lower limb strength along with balance and postural control. Score is the amount of time it takes for an patient to transfer from a seated position to standing position and back to sitting five times.
Measured: Through study completion, an average of 8 months
Mobility
Mobility will be assessed by Timed Up and Go (TUG). TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Measured: Through study completion, an average of 8 months
Secondary outcomes (4)
Stroke Recovery
The lower extremity recovery will be assessed by Brunnstrom Recovery Stages (BRS). The BRS is the most commonly used staging scale for limb function recovery in post-stroke patients. The BRS assessment scores the clinical severity of hemiplegia from 1 to 6. A score of 1 indicates paralysis and 6 indicates normal force and function
Measured: Through study completion, an average of 8 months
Ambulation
The patients' ambulation will be assessed using the Functional Ambulation Category (FAC). FAC evaluates ambulation in 6 categories ranging from 0 to 5. A score of 0 means that the patient is not ambulatory, and 5 indicates normal ambulation.
Measured: Through study completion, an average of 8 months
Independence
Independence will be assessed by the Functional Independence Measure (FIM). FIM is one of the most highly recommended tools for assessing functional recovery in stroke patients. This tool is considered reliable and has been proven to possess high validity for measuring the functional outcomes of stroke patients. FIM consists of 18 items related to daily activities, with a total score ranging from 18 to 126. Each item is rated on a 7-point scale, ranging from 1 (completely dependent) to 7 (independent), based on the level of independence. A total score of ≤108 indicates the need for assistance or limitations in activities.
Measured: Through study completion, an average of 8 months
Muscle Tone
The Muscle Tone of Quadriceps and Gastrocnemius will be measured by using Modified Ashworth Scale. Modified Ashworth Scale tool used to measure the increase of muscle tone in stroke patients. The original Ashworth scale was a 5 point numerical scale that graded spasticity from 0 to 4, with 0 being no resistance and 4 being a limb rigid in flexion or extension.
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start13 May 2025
- Primary completion1 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiçek Günday, Istinye University
- Investigators
- Mansour Dib, Doctor, Study chair, Mgr Cortbawi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965894
- Sponsor's protocol ID
- 02052025
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2025
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pressure Splints on Lower Extremity Functions in Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT06965894
- Acronym / sponsor ID
- 02052025
- Keywords
- Stroke, Rehabilitation, Gait, Johnstone Splint, Motor Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 11 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.
Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke and suffer from hemiplegia. Pressure splints are specialized devices designed to support and enhance muscle function by applying gentle pressure to the affected limbs.
Participants in this study will be randomly assigned to one of two groups: the Splint Group (SG) or the Control Group (CG). The duration of the intervention will be six weeks. During this period, all the participants will receive neurodevelopmental therapy. In the SG exercises will be done with the help of the lower extremity pressure splints while participants in the CG will join the exercises without any splint.
This study is significant as it may lead to the development of new methods to enhance recovery for stroke patients and offer better rehabilitation options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splint Group | Experimental | Device: Johnston Pressure Splint, Other: Rehabilitation ProgramParticipants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques. In addition to the rehabilitation program, a Johnston pressure splint will be applied to the affected lower extremity during therapy sessions. The intervention aims to provide controlled pressure and support to improve motor recovery, balance, and gait in hemiplegic stroke patients. |
| Control Group | Active comparator | Other: Rehabilitation ProgramParticipants in this group will receive a rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques without the pressure splint. This group will serve to compare the effects of standard rehabilitation alone versus rehabilitation combined with pressure splinting. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having hemiplegia because of stroke
- Time since stroke: 1 month to 1 year
- Ability to Participate (a score of >24 on the Mini-Mental State Examination).
- Being voluntary
- Age between 40-80
Key exclusion criteria (1 listed)
- Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke
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 |
|---|---|---|
| Johnston Pressure SplintApplication of a Johnston pressure splint to the lower extremity. | Device | Splint Group |
| Rehabilitation ProgramRehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques. | Other | Control Group, Splint Group |
Primary outcome
Lower Extremity Motor Function
Time frame: Through study completion, an average of 8 months
The improvement in motor function of the lower extremity will be assessed by Fugl-Meyer Assessment for Lower Extremity (FMA). The FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 34.
Balance
Time frame: Through study completion, an average of 8 months
The Berg Balance Scale (BBS) will be used to assess balance. This scale objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Lower Extremity Strength
Time frame: Through study completion, an average of 8 months
The Five Times Sit to Stand Test will be used for the assessment of lower limb strength along with balance and postural control. Score is the amount of time it takes for an patient to transfer from a seated position to standing position and back to sitting five times.
Mobility
Time frame: Through study completion, an average of 8 months
Mobility will be assessed by Timed Up and Go (TUG). TUG is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
4 secondary outcomes
Stroke Recovery
Time frame: Through study completion, an average of 8 months
Ambulation
Time frame: Through study completion, an average of 8 months
Independence
Time frame: Through study completion, an average of 8 months
Muscle Tone
Time frame: Through study completion, an average of 8 months
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Mansour Dib, Doctor study chair
Mgr Cortbawi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Johnston Pressure Splint and Rehabilitation Program in people with Hemiplegia and Lower Extremity Dysfunction, run by Istinye University at 1 site in Lebanon.
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 1 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 16 Jun 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 Lebanon. 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?
Lower Extremity Motor Function (time frame: Through study completion, an average of 8 months). The study lists 4 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 16 Jun 2026.