Clinical trial NCT07027215: Augmented Sensory in Cancer-Related Neuropathic Patients"
Official title: Impact of Augmented Sensory Feedback on Motor Control and Risk of Falling in Cancer-Related Neuropathic Patients"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Lead sponsor: Isra University, Jordan
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this research studied the effect of augmented sensory feedback program on motor control and risk of falling in patient with CIPN.

Detailed description: Design: A randomized control trial was conducted to investigate the impact of augmented sensory feedback paradigm on motor control and risk of falling in patient with Chemotherapy-induced peripheral neuropathy. Data were collected pre and post treatment from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024. The study was approved by the ethical committee of the Faculty of Physical Therapy, South Vally University, Egypt. The study protocol was explained in detail to every patient and signed written consent was obtained before participation.

Participants: forty female patients with CIPN were recruited from out-patient clinic of the Faculty of Medicine and Faculty of Physical Therapy South Valley University, between January 2023and March 2024.

Eligibility criteria: Inclusion Criteria:

* Forty female with age from 35-60 years
* clinically diagnosed with CIPN after recovery from stage I or II breast cancer
* The strength at the toes, ankles, knees, and hips, as determined by manual muscle tests, of at least 3/5.
* The patients can walk independently with or without any assistive devices.

Exclusion Criteria:

* Patients with a history of hereditary peripheral neuropathy
* Diseases that may contribute to peripheral nerve damage, such as diabetes or renal insufficiency, alcohol abuse, HIV, and vasculitis.
* Patient who had central or peripheral neurologic disease, brain or spinal cord metastases
* Orthopedic problems influencing gait, or foot ulcer at the moment of intake.
* Patients with vestibular or neurological problems influencing gait parameters
* Subjects who had participated in regular exercise, as defined as 150 min of light-to-moderate intensity exercise per week over the past year, were excluded from this trial.

Primary outcomes:
measure: improvement of balance which was assessed by fall risk scale
timeFrame: one and half month
measure: Stability measures
timeFrame: one and half month
measure: Sensory feedback
timeFrame: one and half month
Secondary outcomes:
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: Faculty of Physical Therapy South Valley University
state: Qena Governorate
Study officials:
affiliation: Isra university. Amman.jordan
name: Abeer A Mohammed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.
citation: Schneberger S. "Prolife" perinatologist. N Engl J Med. 1992 Sep 10;327(11):812; author reply 813-4. No abstract available.
citation: Sienko KH, Seidler RD, Carender WJ, Goodworth AD, Whitney SL, Peterka RJ. Potential Mechanisms of Sensory Augmentation Systems on Human Balance Control. Front Neurol. 2018 Nov 12;9:944. doi: 10.3389/fneur.2018.00944. eCollection 2018.