Lower Extremity Pressure Splints in HP

NCT ID: NCT06965894

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hemiplegia Lower Extremity Dysfunction Stroke Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Johnston Pressure Splint

Intervention Type DEVICE

Application of a Johnston pressure splint to the lower extremity.

Rehabilitation Program

Intervention Type OTHER

Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.

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.

Group Type ACTIVE_COMPARATOR

Rehabilitation Program

Intervention Type OTHER

Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.

Interventions

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Johnston Pressure Splint

Application of a Johnston pressure splint to the lower extremity.

Intervention Type DEVICE

Rehabilitation Program

Rehabilitation program including neurodevelopmental therapy and proprioceptive neuromuscular facilitation (PNF) techniques.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istinye University

OTHER

Sponsor Role lead

Responsible Party

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Çiçek Günday

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mansour Dib, Doctor

Role: STUDY_CHAIR

Mgr Cortbawi Hospital

Locations

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Monseigneur Cortbawi Hospital

Jounieh, Keserwan, Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Çiçek Günday, Asst. Prof.

Role: CONTACT

0090 850 283 60 00

Ousama Maarbani, Physiotherapist

Role: CONTACT

0090 850 283 60 00

Facility Contacts

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Mansour Dib, Doctor

Role: primary

70-104-154

Pierre Merheb, PhD

Role: backup

70-281-271

Other Identifiers

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02052025

Identifier Type: -

Identifier Source: org_study_id

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