Lower Extremity Pressure Splints in HP

Istinye University

Status: Enrolling

Conditions: Stroke Rehabilitation; Lower Extremity Dysfunction; Hemiplegia

Treatments: Device: Johnston Pressure Splint; Other: Rehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06965894

02052025

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Splint Group

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation Program

Device: Johnston Pressure Splint

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Rehabilitation Program