The Effects of AFO Heel Height and Stiffness on Gait (AFOHeel)

December 29, 2025 updated by: Jason Wilken, University of Iowa

The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators to evaluate the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited.

Two groups of subjects with impairments below the knee, that result in functional deficits and require daily AFO use, will be recruited for this study. The first group will have unilateral deficits associated with musculoskeletal injury or disease (Group 1), and the second group will have bilateral or unilateral deficits associated with peripheral nervous system disease (Group 2).

Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. Participants will walk with their clinically provided AFO, with added heel cushions of two different heights and stiffness's (4 conditions) at a controlled velocity and self-selected velocity. If able, they will walk without their AFO at a self-selected pace. Participants will be asked to provide information regarding their health condition and opinions of the conditions tested.

Study Type

Interventional

Enrollment (Estimated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jason M Wilken, PT, PhD
Phone Number: 319-335-6857
Email: jason-wilken@uiowa.edu

Study Contact Backup

Name: Kirsten M Anderson, PhD
Phone Number: 319-353-0431
Email: kirsten-m-anderson@uiowa.edu

Study Locations

United States
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa
    - Contact:
      
      Jason M Wilken, PT, PhD
      
      Phone Number: 319-335-6857
      
      Email: jason-wilken@uiowa.edu
    - Sub-Investigator:
      
      Molly Pacha, MS, ATC, LAT
    - Principal Investigator:
      
      Jason M Wilken, PT, PhD
    - Contact:
      
      Kirsten M Anderson, PhD
      
      Phone Number: 319-353-0431
      
      Email: kirsten-m-anderson@uiowa.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

GROUP 1 Patient Inclusion criteria

Ages: 18-70
Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis)
Greater than 2 weeks using their current AFO
Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
Ability to walk at a slow to moderate pace
AFO fits into traditional footwear
Able to read and write in English and provide written informed consent

GROUP 1 Patient Exclusion criteria

Pain > 6/10 while walking during testing or an increase in pain during testing of > 2/10.
Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).
Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).
Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder.
Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
Use of an AFO that crosses the knee (Knee brace)
Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing
Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.
Body Mass index > 40.

GROUP 2 Patient Inclusion Criteria

Ages: 18-70
Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)
Greater than 2 weeks using their current AFO (unilateral or bilateral)
Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
AFO fits into traditional footwear
Ability to walk at a slow to moderate pace
Able to read and write in English and provide written informed consent

GROUP 2 Patient Exclusion Criteria

Pain > 6/10 while walking or an increase in pain during testing of > 2/10
Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)
Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury)
Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
Use of an AFO that crosses the knee (Knee brace)
Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study
Body Mass index > 40.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 2: Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 3: Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 4: Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 5: Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 6: Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 7: Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 8: Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 9: Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 10: Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 11: Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 12: Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 13: Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 14: Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 15: Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 16: Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 17: Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 18: Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 19: Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 20: Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 21: Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 22: Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 23: Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF
Experimental: Arm 24: Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO	Device: Tall Soft Tall heel wedge made of soft foam Other Names: TS Device: Tall Firm Tall heel wedge made of firm foam Other Names: TF Device: Short Soft Short heel wedge made of soft foam Other Names: SS Device: Short Firm Short heel wedge made of firm foam Other Names: SF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Rating Scale Time Frame: Baseline	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.	Baseline
Center of pressure velocity timing Time Frame: Baseline	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Center of pressure velocity magnitude Time Frame: Baseline	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline
Participant wedge preference Time Frame: Baseline	The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.	Baseline
Modified Socket Comfort Score (Comfort) Time Frame: Baseline	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.	Baseline
Modified Socket Comfort Score (Smoothness) Time Frame: Baseline	Smoothness scores range from 0 = least smooth to 10 = most smooth.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Range of Motion Time Frame: Baseline	Ankle range of motion (degrees) during gait.	Baseline
Peak Ankle Moment Time Frame: Baseline	Peak ankle moment (Nm/kg) during gait.	Baseline
Peak Ankle Power Time Frame: Baseline	Peak ankle power (W/kg) during gait.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities-Specific Balance Confidence (ABC) Time Frame: Baseline	The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.	Baseline
PROMIS Patient reported outcomes for physical function Time Frame: Baseline	The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

201811701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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The Effects of AFO Heel Height and Stiffness on Gait (AFOHeel)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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