NCT07756073

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting side effect of neurotoxic chemotherapy agents, characterized by sensory loss, impaired proprioception, and muscle weakness, predominantly affecting the lower limbs. These impairments significantly contribute to postural instability and increase fall risk in elderly patients. Additionally, CIPN-associated microvascular changes can compromise peripheral circulation, further exacerbating neuromotor dysfunction and balance deficits. While pharmacological options for CIPN are limited and often inadequate, exercise-based interventions have shown promise in mitigating functional impairments. Buerger's exercises, a vascular stimulation technique, are known to enhance peripheral blood flow, whereas proprioceptive drills can improve neuromuscular coordination and postural control. However, their combined effect on both postural stability and foot perfusion in elderly patients with CIPN has not been systematically studied.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress14%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 25, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 27, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Buerger's Exercises - Proprioceptive Drills - Postural Stability -Foot Perfusion - Elderly Patients - Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

  • Postural Stability Foot Perfusion

    .Postural Stability: Overall Stability Index (OSI) via Biodex Balance System SD Foot Perfusion: Laser Doppler Flowmetry (LDF)

    Week 8

  • Pain scale (VAS) Quality of Life Index (QLI) - SCI Version

    Pain scale (VAS) The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Quality of Life Index (QLI) - SCI Version Comprised of 4 domains: 1. Health and functioning 2. Psychological/spiritual 3. Social and economic 4. Family.

    8 weeks

  • Weight Height Body mass index

    Weight in kg, height in meter and body mass index in kg/m2

    8 weeks

Secondary Outcomes (1)

  • Secondary Outcomes

    8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention Group (35 participants) will receive Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks: * Buerger's Exercises: * Leg elevation at 45° for 2 min until blanching * Dependent sitting for 3 min until hyperemia * Supine rest for 5 min * 3 cycles per session * Proprioceptive Drills: * Single-leg stance * Tandem stance/walking * Heel-to-toe walking * Anterior-posterior and lateral weight shifts * Mini-squats on foam * Ankle alphabet * Progressively increased difficulty Sessions supervised by trained physiotherapists.

Combination Product: Buerger's Exercises

Control Group

ACTIVE COMPARATOR

Control Group (35 participants) will receive Standard care with educational leaflets and physical activity advice.

Combination Product: Buerger's Exercises

Interventions

Buerger's ExercisesCOMBINATION_PRODUCT

Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks: * Buerger's Exercises: * Leg elevation at 45° for 2 min until blanching * Dependent sitting for 3 min until hyperemia * Supine rest for 5 min * 3 cycles per session * Proprioceptive Drills: * Single-leg stance * Tandem stance/walking * Heel-to-toe walking * Anterior-posterior and lateral weight shifts * Mini-squats on foam * Ankle alphabet * Progressively increased difficulty Sessions supervised by trained physiotherapists.

Control GroupIntervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or older
  • Diagnosed with CIPN for at least 3 months
  • Demonstrating impaired postural stability (BBS ≤ 48 or ≥2 falls in the past year)
  • Medically cleared for exercise
  • Cognitively intact (MMSE ≥ 24)
  • Willing and able to give consent

You may not qualify if:

  • Severe peripheral arterial disease (ABI \< 0.5)
  • Severe postural hypotension or positional syncope
  • Recent orthopedic procedures or fractures (past 6 months)
  • Vestibular or cerebellar disorders
  • Uncontrolled systemic diseases
  • Cognitive impairment (MMSE \< 24)
  • Concurrent participation in another structured balance or vascular program
  • Lower limb ulcers or active infection
  • Severe visual impairment
  • Intolerance to positional exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.

  • Chang CF, Chang CC, Hwang SL, Chen MY. Effects of Buerger Exercise Combined Health-Promoting Program on Peripheral Neurovasculopathy Among Community Residents at High Risk for Diabetic Foot Ulceration. Worldviews Evid Based Nurs. 2015 Jun;12(3):145-53. doi: 10.1111/wvn.12091. Epub 2015 May 11.

Related Links

Central Study Contacts

ibrahim abuzaid, Assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department physical therapy for cardiovascular/Respiratory disorders and Geriatrics

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 10, 2026

Study Start

July 25, 2026

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08