ANKLE_ROM: Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.

• Sponsor: University of Valencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03743857
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 28.9

Study Details

Study Description

Brief Summary

The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.

Condition or Disease	Intervention/Treatment	Phase
Aging Problems	Procedure: Manual Therapy	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 of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial
• Actual Study Start Date: Dec 1, 2018
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Jan 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manual Therapy 6 sessions of ankle manual therapy	Procedure: Manual Therapy; AP ankle mobilization
No Intervention: Control No intervention

Outcome Measures

Primary Outcome Measures

1. Test Up and Go [Change from baseline to day 21]

   It is a test in which the functional mobility of the participant is measured.

2. One Leg Balance Test [Change from baseline to day 21]

   The time that the participant can be with monopodal support is measured

3. Functional Reach Test [Change from baseline to day 21]

   It measures the ability to move the center of gravity forward without losing balance.

4. Analysis of Center of Pressure [Change from baseline to day 21]

   Measurement of the displacement of the center of pressures using a Pressure Platform.

Secondary Outcome Measures

1. Active ankle range of movement [Change from baseline to day 21]

   Measurement of the total active joint range of the ankle in discharge with a goniometer.

2. Weight Bearing Dorsiflexion Lunge Test [Change from baseline to day 21]

   Measurement of dorsiflexion of the ankle under load with an inclinometer.

3. Falls Efficacy Scale [Change from baseline to day 21]

   Scale that measures the worry of suffering a fall.

4. Assessment of ankle plantar flexion muscle strength [Change from baseline to day 21]

   Measurement of the strength of the plantar flexion of the ankle with a dynamometer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 60 years or more

Exclusion Criteria:

• Do not sign the consent

• No acute pathology (3 months)

• Vestibular pathology

• CNS disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Valencia	Valencia		Spain	46010

Sponsors and Collaborators

• University of Valencia

Investigators

• Principal Investigator: David Hernández-Guillén, 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: NCT03743857
• Other Study ID Numbers: DHG03
• First Posted: Nov 16, 2018
• Last Update Posted: Jan 29, 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: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Hernández, Principal Investigator, University of Valencia: Ankle; Balance; Manual Therapy; Older Adult

Study Results

No Results Posted as of Jan 29, 2019