Lower Extremity Pressure Splints in HP

May 14, 2025 updated by: Çiçek Günday, Istinye University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 50-80

Exclusion Criteria:

Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Splint Group
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.
Other: Rehabilitation Program
Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.
Device: Johnston Pressure Splint
Application of a Johnston pressure splint to the lower extremity.
Active Comparator: Control Group
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.
Other: Rehabilitation Program
Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Recovery
Time Frame: Through study completion, an average of 8 months
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
Through study completion, an average of 8 months
Ambulation
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
Independence
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
Muscle Tone
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Investigators

  • Study Chair: Mansour Dib, Doctor, Mgr Cortbawi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

January 13, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02052025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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