Arm-in-Arm Gait Training Trial

NCT05627453 | Recruiting DMC

• 1 other identifier: 2022-01452
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The AAGaTT study, is a monocentric, two-arm, open-label, randomized controlled trial. The objective is to assess the efficacy of an arm-in-arm walking program for older people at risk of falling. Gait training imply that the older participants must walk while synchronizing steps with a younger partner.

Conditions

Healthy Aging

Keywords

fall risk; gait disorder; physical activity; complexity matching

Outcome Measures

Primary Outcomes (1)

• Walking speed

  Habitual (preferred) walking speed to cover 200m. Normal values for older men: 1.21m/s -1.32m/s), older women 1.07m/s -1.19m/s).

  Week 4

Secondary Outcomes (85)

• Walking speed

  Baseline

• Walking speed

  Week 1

• Walking speed

  Week 2

• Walking speed

  Week 3

• Walking speed

  Week 7 (follow-up)

Study Arms (2)

Normal gait training

ACTIVE COMPARATOR

The gait training session will consist in 30 min walking side-by-side. If any, the session will take place along an indoor circuit to avoid unfavorable weather conditions. The participants will walk side by side without contact and without instructions about gait synchronisation. They will have to agree on a comfortable pace for the older participant. The gait training session will be repeated three times a week for four weeks. The last session of each week will also include an assessement of gait quality.

Other: Normal gait training

Arm-in-arm gait training

EXPERIMENTAL

The gait training session will consist in 30 min walking side-by-side. If any, the session will take place along an indoor circuit to avoid unfavorable weather conditions. The participants will be asked to walk arm-in-arm while synchronizing their steps. They will have to agree on a comfortable pace for the older participant. The gait training session will be repeated three times a week for four weeks. The last session of each week will also include an assessement of gait quality.

Other: Arm-in-arm gait training

Interventions

Arm-in-arm gait training OTHER

An older adult walk side-by-side, arm-in-arm with a younger adult while synchronizing steps.

Arm-in-arm gait training

Normal gait training OTHER

An older adult walk side-by-side, without contact, with a younger adult without step synchronization.

Normal gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older Participant
• Older than 70 years old
• Able to walk continuously during 15 minutes without walking aids.
• Must have experienced a fall during the last year before the recruitment.
• Health certificate that attests no contraindication to walking
• No severe gait disorders from orthopedic or neurologic origins (such as lower-limb amputation or severe hemiparesis). Mild gait abnormalities (for example, mild limping due to knee arthritis, or slight gait asymmetry due to limited hemiparesis) will be tolerated.
• Younger Participant
• Older than 18 years old but younger than 40 years old.
• No severe gait disorders from musculoskeletal or neurologic origin.

You may not qualify if:

• Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.;
• Inability or contraindications to undergo the investigated intervention.
• Vulnerable persons, in sense of swiss Human Research Act art. 21-24.

Sponsors & Collaborators

• Philippe Terrier: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Haute-Ecole Arc Santé

Neuchâtel, 2000, Switzerland

RECRUITING

Related Publications (8)

• Ghai S, Ghai I, Effenberg AO. Effect of Rhythmic Auditory Cueing on Aging Gait: A Systematic Review and Meta-Analysis. Aging Dis. 2018 Oct 1;9(5):901-923. doi: 10.14336/AD.2017.1031. eCollection 2018 Oct.

  PMID: 30271666 BACKGROUND

• Van Abbema R, De Greef M, Craje C, Krijnen W, Hobbelen H, Van Der Schans C. What type, or combination of exercise can improve preferred gait speed in older adults? A meta-analysis. BMC Geriatr. 2015 Jul 1;15:72. doi: 10.1186/s12877-015-0061-9.

  PMID: 26126532 BACKGROUND

• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.

  PMID: 30703272 BACKGROUND

• Almurad ZMH, Roume C, Blain H, Delignieres D. Complexity Matching: Restoring the Complexity of Locomotion in Older People Through Arm-in-Arm Walking. Front Physiol. 2018 Dec 4;9:1766. doi: 10.3389/fphys.2018.01766. eCollection 2018.

  PMID: 30564149 BACKGROUND

• Terrier P, Le Carre J, Connaissa ML, Leger B, Luthi F. Monitoring of Gait Quality in Patients With Chronic Pain of Lower Limbs. IEEE Trans Neural Syst Rehabil Eng. 2017 Oct;25(10):1843-1852. doi: 10.1109/TNSRE.2017.2688485. Epub 2017 Mar 28.

  PMID: 28368823 BACKGROUND

• Terrier P, Reynard F. Maximum Lyapunov exponent revisited: Long-term attractor divergence of gait dynamics is highly sensitive to the noise structure of stride intervals. Gait Posture. 2018 Oct;66:236-241. doi: 10.1016/j.gaitpost.2018.08.010. Epub 2018 Aug 14.

  PMID: 30212783 BACKGROUND

• Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11.

  PMID: 21820535 BACKGROUND

• Gigonzac M, Terrier P. Restoring walking ability in older adults with arm-in-arm gait training: study protocol for the AAGaTT randomized controlled trial. BMC Geriatr. 2023 Sep 6;23(1):542. doi: 10.1186/s12877-023-04255-9.

  PMID: 37674129 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Philippe Terrier, PhD

  Haute-Ecole Arc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Terrier, PhD

CONTACT

+41 32 930 12 55; philippe.terrier@he-arc.ch

Jeremy Torrent, MSc

CONTACT

+41 32 930 12 73; jeremy.torrent@he-arc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible due to the nature of the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: The AAGaTT study, is a monocentric, two-arm, open-label, randomized controlled trial. The superiority of arm-in-arm synchronized gait training will be assessed versus standard walking (i.e., walking side-by-side without gait synchronization).

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 25, 2022
• Study Start: January 20, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol will be published within 6 months after first recruitment. Anonymized dataset and acceleration data will be uploaded in parallel of result publications, within one year after the end of the study
• Access Criteria: Study shared data will be publicly available on an open-access website following the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles (zenodo.org).

Locations

CH (1)