NCT03340584

Brief Summary

The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 25, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

November 8, 2017

Last Update Submit

July 24, 2019

Conditions

Total Knee Replacement

Keywords

Total Knee ReplacementTapingRehabilitationEdemaPain

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Knee Edema at 1 week

    Leg Circumference Measurements

    Baseline and at 1 week

Secondary Outcomes (4)

  • Change from Baseline Activities of Daily Living (ADL) at 1 week

    Baseline and at 1 week

  • Change from Baseline Knee Pain at 1 week

    Baseline and at 1 week

  • Change from Baseline Knee range of motion at 1 week

    Baseline and at 1 week

  • Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week

    Baseline and at 1 week

Study Arms (2)

The intervention group

EXPERIMENTAL

The intervention group will be received the Nine Castle Net Format taping and the traditional rehabilitation throughout all hospitalization period.We will exchange the new taping for Every two days.

Other: the Nine Castle Net Format Taping

The control group

OTHER

The control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy.

Other: traditional rehabilitation

Interventions

the Nine Castle Net Format TapingOTHER

The intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days， for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.

The intervention group
traditional rehabilitationOTHER

traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.

The control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • soft-tissue swelling and pain after total knee replacement
  • agree to participate the study and signing of informed consent

You may not qualify if:

  • severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling
  • failure of important organs, such as heart, lung, liver and kidney
  • deep venous thrombosis
  • thrombophlebitis
  • varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer)
  • participants with infection in the areas close to the knee joint, or allergy to tape
  • enrollment in another clinical trial involving physical therapy or an investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songhe Jiang

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

EdemaPain

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Central Study Contacts

Songhe Jiang

CONTACT

8613600661860863191168@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 13, 2017

Study Start

November 25, 2017

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

CN(1)