Clinical trial NCT05962060: PNF With and Without EMS on Spasticity, Gait and Lower Limb Function in Chronic Stroke Patients
Official title: Effect of Proprioceptive Neuromuscular Facilitation With and Without Electrical Muscle Stimulation on Spasticity, Gait and Lower Limb Functions of Chronic Stroke Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: Electrical Muscle Stimulation
Proprioceptive Neuromuscular Facilitation
Physiotherapy
Spasticity
Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of conducting this study is to decrease the tone through PNF techniques and EMS application. By decreasing the tone, spasticity may be reduced in stroke patients and may inturn lead to better approaches to treat those patients. So, the findings of this study can help in formulation of future guidelines for management of stroke that will help the clinicians to treat such patients in more efficient way..

Detailed description: A RCT that investigated the effects of PNF interventions in patients of chronic stroke using balance and gait as outcome measures. 19 studies with 532 participants were included, of which 12 studies with 327 participants were included for meta-analysis. When data was pooled, PNF made significantly improvement in balance and gait of chronic stroke patients. This review indicates that PNF is a potential treatment strategy in chronic stroke rehabilitation on balance and gait.

A systematic review to investigate the effects of proprioceptive neuromuscular facilitation (PNF) on spasticity post-stroke. Six studies were included in this systematic review. Three were pilot studies, clinical controlled trials, and randomized controlled trials. The findings of this study showed evidence on the benefits of the PNF intervention on spasticity post-stroke.

A study is to identify the effectiveness of proprioceptive neuromuscular facilitation (PNF) leg Kinesio taping on gait parameters and dynamic balance in chronic stroke patients with foot drop. A total 22 chronic stroke patients were randomly assigned to experimental and control groups. All subjects underwent conventional therapy and gait training for 50 mints. All of the measurements were performed baseline and 24 h after intervention. The Results of this study yields that the short-term effect of application of lower-leg KT according to the PNF pattern increased the gait ability and dynamic balance of chronic stroke patients with foot drop.

GAP: As it is evident from the literature that PNF and EMS has beneficial effects in the treatment of chronic stroke patients and little work has been done on seeing the mechanism of its effects on upper limb of chronic stroke patients. But up to the researcher's knowledge least work has been done on seeing its effects in specifically lower limb and gait of stroke patients. So, in this study the effects of PNF with and without EMS will be documented in the lower limb of stroke patients in terms of spasticity and their gait.

Eligibility criteria: Inclusion Criteria:

* Age 50-65 years old
* Both male and female patients
* Glasgow Coma Scale(GCS) score more than 10
* Mini Mental Scale Examination Score(MMSE) more than 18
* Patient with MMT grade 3+

Exclusion Criteria:

* Demyelinating diseases.
* Trumatic head injury
* Psychological or psychiatric disorder
* Myopathies, Peripheral Nerve Injury
* Tumors
* Recent fractures
* Visual, hearing deficits
* Any history of fall
* Seizures.
* Cardiac issues.

Primary outcomes:
measure: Dynamic Gait Index without Electrical muscle stimulation on spasticity, gait and lower limb function in chronic stroke patients
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Modified Barthel index scale
timeFrame: 4 weeks
measure: Modified Ashworth Scale
timeFrame: 4 weeks
measure: Mini-Mental scale examination
timeFrame: 4 weeks
measure: Glasgow coma scale
timeFrame: 4 weeks
Locations:
city: Sheikhupura
country: Pakistan
facility: DHQ hospital Sheikhupra
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen PT, Chou LW, Hsieh YL. Proprioceptive Neuromuscular Facilitation-Based Physical Therapy on the Improvement of Balance and Gait in Patients with Chronic Stroke: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Jun 13;12(6):882. doi: 10.3390/life12060882.
citation: Parry SM, Berney S, Granger CL, Koopman R, El-Ansary D, Denehy L. Electrical muscle stimulation in the intensive care setting: a systematic review. Crit Care Med. 2013 Oct;41(10):2406-18. doi: 10.1097/CCM.0b013e3182923642.
citation: Lee D, Bae Y. Short-Term Effect of Kinesio Taping of Lower-Leg Proprioceptive Neuromuscular Facilitation Pattern on Gait Parameter and Dynamic Balance in Chronic Stroke with Foot Drop. Healthcare (Basel). 2021 Mar 3;9(3):271. doi: 10.3390/healthcare9030271.
citation: Nakanishi N, Oto J, Tsutsumi R, Yamamoto T, Ueno Y, Nakataki E, Itagaki T, Sakaue H, Nishimura M. Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial. Crit Care Med. 2020 Nov;48(11):e997-e1003. doi: 10.1097/CCM.0000000000004522.