An interventional study of mechanical compression therapy and Exercises in Polyneuropathies, Regional Blood Flow and Lower Extremity, sponsored by Damanhour University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Damanhour University · Not applicable, Interventional, and Supportive care
Chemotherapy-induced peripheral neuropathy (CIPN) and impaired lower-limb circulation are common adverse effects that can compromise patients' mobility, comfort, balance, functional independence, and quality of life and may increase the risk of falls. Although Buerger-Allen exercises and mechanical compression therapy are non-pharmacological approaches that may improve peripheral circulation and alleviate neuropathic symptoms, evidence directly comparing these interventions among patients receiving chemotherapy remains limited, particularly in Egypt. This study will address this gap and may inform feasible, nurse-led strategies for supportive oncology care.
Aim of the study:
This study will aim to compare the effects of Buerger-Allen exercises and mechanical compression therapy on lower-limb perfusion and peripheral neuropathy among patients undergoing chemotherapy.
Randomized control trail research design will be used. Setting The study will be conducted in the inpatient chemotherapy department at Ayady Almostakbal Cancer Treatment Hospital, Alexandria Governorate, Egypt. The hospital is a specialized, non-governmental, charitable medical center that provides cancer treatment services to residents of Alexandria Governorate and surrounding areas.
Subjects:
A purposive sample of 100 eligible patients will be recruited and allocated equally to two intervention groups: the Buerger-Allen exercise group (n = 50) and the mechanical compression therapy group (n = 50).
Inclusion criteria:
Exclusion criteria:
Tools for data collection:
Two principal assessment tools will be used for data collection.
Tool 1: Lower-Limb Perfusion Assessment. This tool will be developed by the researchers following a comprehensive review of the relevant literature and will consist of three parts:
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 100 is above the median of 63 across 70 interventional studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →Damanhour University is the lead sponsor of 78 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.
Other: Exercises
Devise
Device: mechanical compression therapy
\- Participants in Group 2 will receive mechanical compression therapy once during each chemotherapy session for one month, for a total of three sessions, with each session lasting 20 minutes.
Buerger-Allen exercises. The researchers will explain and demonstrate the exercise and will ask each participant to return-demonstrate the following three steps: * Step 1-Elevation: The participant's lower extremities will be elevated to approximately 45° and supported in this position until blanching occurs, for approximately three minutes. * Step 2-Dependency: The participant's feet and legs will then be lowered below the level of the body until redness appears, for approximately 10 minutes. * Step 3-Horizontal rest: The participant's legs will be placed flat on the bed for 10 minutes. * The three-step Buerger-Allen exercise cycle will be repeated three times per session. Participants will be instructed to complete three sessions per day for five consecutive days, with performance monitored and reinforced by the researchers.
Change in lower-limb circumference measured using a non-stretch measuring tape
Lower-limb circumference will be measured in centimeters using a non-stretch measuring tape at the mid-thigh, calf, and above the ankle of each lower limb. The same anatomical landmark and procedure will be used at every assessment. A lower circumference may indicate reduced swelling or edema. Right- and left-limb measurements will be recorded separately.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in lower-limb skin temperature assessment by palpation using the back of the fingers
Lower-limb skin temperature will be assessed by palpation using the back of the fingers. Measurements will be recorded separately for the right and left lower limbs.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in lower-limb capillary refill time assessed by the blanching test
Capillary refill time will be assessed by applying pressure to the distal toe until blanching occurs and measuring the time required for normal color to return after pressure is released. The result will be recorded in seconds. A shorter capillary refill time indicates better peripheral perfusion. Each lower limb will be assessed separately.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in distal pedal pulse strength assessed using a standardized pulse-grading scale
Dorsalis pedis and posterior tibial pulse strength will be assessed by palpation and graded as 0 = absent, 1 = weak, 2 = normal, and 3 = bounding. Higher scores indicate stronger palpable distal pulses. Each pulse site and lower limb will be documented separately.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in lower-limb edema assessed using the pitting-edema grading scale
Pitting edema will be assessed by applying standardized pressure over the lower limb and grading the resulting indentation using a 0-4+ scale, where 0 indicates no pitting edema and 1+ to 4+ indicate increasing severity. Higher scores indicate more severe edema. Each lower limb will be assessed separately.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in active ankle dorsiflexion measured using a goniometer
Active ankle dorsiflexion will be measured using a standard goniometer while the participant actively moves the ankle through the available range. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater active range of motion.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
Change in passive ankle dorsiflexion measured using a goniometer
Passive ankle dorsiflexion will be measured using a standard goniometer while the assessor moves the participant's ankle through the available range without active effort from the participant. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater passive range of motion.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
lower-limb sensation assessed using the adapted Peripheral Neuropathy Assessment Tool
Lower-limb sensation will be assessed using the sensation component of the researcher-adapted Peripheral Neuropathy Assessment Tool based on Abouelala et al. (2022) including light touch, pinprick, vibration. Each lower limb will be assessed separately at prespecified anatomical sites using the standardized procedures and response categories defined in the finalized assessment tool. Sensation will be classified as intact or impaired. The outcome will be reported as the number of participants with impaired lower-limb sensation.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
lower-limb pain intensity assessed using the Numeric Rating Scale
Participants will rate lower-limb pain intensity on a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain. If both limbs are painful, pain will be assessed separately for each limb or according to a prespecified rule identifying the most symptomatic limb.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
lower-limb skin color assessed by standardized clinical inspection
Lower-limb skin color will be assessed by standardized clinical inspection and classified using prespecified categories in the Lower-Limb Perfusion Assessment, such as normal color, pallor, cyanosis, or dependent rubor. The outcome will be reported as the number of participants in each category.
Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Damanhour University