NCT07027215

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 7, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

December 22, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 7, 2025

Last Update Submit

December 15, 2025

Conditions

Physical Therapy

Outcome Measures

Primary Outcomes (3)

  • improvement of balance which was assessed by fall risk scale

    improvement in feet sensitivity and motor control and risk of falling in both groups in favor of the study group.

    one and half month

  • Stability measures

    postural stability was measured using a Biodex Balance System SD (950-440 with version 4.X software)

    one and half month

  • Sensory feedback

    Sensory feedback was assessed by using Semmes-Weinstein monofilament (SWM)

    one and half month

Study Arms (2)

control group 20 Patients"

ACTIVE COMPARATOR

Cancer-Related Neuropathic Patients"

Combination Product: selected physical therapy program as arm excercises

study group 20 Patients"

ACTIVE COMPARATOR

Cancer-Related Neuropathic Patients"

Combination Product: Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF technique

Interventions

Gradual Intermittent pneumatic compression therapy (IPC),Balance excercises.PNF techniqueCOMBINATION_PRODUCT

PNF technique

Also known as: Balance Exercises
study group 20 Patients"
selected physical therapy program as arm excercisesCOMBINATION_PRODUCT

selected physical therapy program only. The program consisted of (core exercises, AROM exercises, and stretching exercises for LL for 18 sessions every other day, over 6 weeks

control group 20 Patients"

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patients
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy South Valley University

Luxor, Qena Governorate, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 25261162RESULT

  • Schneberger S. "Prolife" perinatologist. N Engl J Med. 1992 Sep 10;327(11):812; author reply 813-4. No abstract available.

    PMID: 1501662RESULT

  • 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.

    PMID: 30483209RESULT

Study Officials

  • Abeer A Mohammed, PhD

    Isra university. Amman.jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture of physical Therapy, Department of Neuromuscular Disorder, Faculty for Physical Therapy, Cairo University, Cairo, Egypt

Study Record Dates

First Submitted

June 7, 2025

First Posted

June 18, 2025

Study Start

January 20, 2024

Primary Completion

March 25, 2024

Study Completion

May 30, 2024

Last Updated

December 22, 2025

Record last verified: 2025-06

Locations

EG(1)