NCT06168240

Brief Summary

Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Theories on MLDTs address functions like stimulating the lymphatic system by increasing lymph circulation, facilitating the removal of waste products from body tissues, reducing edema, and decreasing the responses of sympathetic nervous system while increasing the parasympathetic nervous tone leading to a relaxed body state.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 20, 2023

Last Update Submit

February 9, 2024

Conditions

Keywords

Ankle sprainAthletesManual lymphatic drainage

Outcome Measures

Primary Outcomes (2)

  • static balance

    Flamingo Balance Test to assess static balance

    starting and after 4 weeks

  • dynamic postural balance

    Star Excursion Balance Test to assess dynamic postural balance

    starting and after 4 weeks

Secondary Outcomes (3)

  • Pain intensity

    starting and after 4 weeks

  • swelling

    starting and after 4 weeks

  • range of motion

    starting and after 4 weeks

Study Arms (2)

group A

EXPERIMENTAL

will receive Manual lymphatic drainage plus Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks.

Other: Manual lymphatic drainage. will be applied three days per week for four weeks.

group B

ACTIVE COMPARATOR

will receive Traditional physical therapy program only that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks.

Other: Manual lymphatic drainage. will be applied three days per week for four weeks.

Interventions

Training will applied 3 days a week, for a total of 4 weeks.

Also known as: Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program). will applied three days per week for four weeks.
group Agroup B

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Basketball Athletes patients diagnosed as acute and post-acute ankle sprain. 2. Patients within 18 and 30 years old. 3. Patients with grade I, II ankle inversion sprain. 4. All participants complains of pain and moderate swelling in the ankle.

You may not qualify if:

  • Previous ankle surgery.
  • Serious pathology.
  • History of fractures in the ankle joint.
  • Vascular disorders.
  • Grade III ankle sprain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

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
SPONSOR INVESTIGATOR
PI Title
master

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 13, 2023

Study Start

February 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02