ANKLE_ROM: Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT03600402

Collaborator

(none)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.

Condition or Disease	Intervention/Treatment	Phase
Aging Problems	Other: Experimental Other: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People: Randomized Clinical Trial

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Nov 12, 2018

Actual Study Completion Date :

Jan 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group	Other: Experimental 6 sessions of ankle manual therapy
Other: Control Group	Other: Control 6 sessions of placebo intervention

Arm

Intervention/Treatment

Experimental: Experimental Group

Other: Experimental

6 sessions of ankle manual therapy

Other: Control Group

Other: Control

6 sessions of placebo intervention

Outcome Measures

Primary Outcome Measures

Active ankle range of movement [Change from baseline to day 1, 3, 5, 8, 10, 12, 19 and 48]
Measurement of the anterior tilt of the tibia during weight bearing with an inclinometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age
Ankle dorsiflexion limitation

Exclusion Criteria:

Do not sign the consent
No injuries in the foot
No acute pathology (3 months) in lower limb

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Valencia	Valencia		Spain	46010

Sponsors and Collaborators

University of Valencia

Investigators

Principal Investigator: David Hernández, PT, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Hernández, Principal Investigator, University of Valencia

ClinicalTrials.gov Identifier:

NCT03600402

Other Study ID Numbers:

DHG02

First Posted:

Jul 26, 2018

Last Update Posted:

Jan 4, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Hernández, Principal Investigator, University of Valencia

Study Results

No Results Posted as of Jan 4, 2019