The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly

NCT05475652 | Unknown

• 1 other identifier: 002B2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

Conditions

Balance, Postural; Gait; Elderly

Keywords

senior;; gait; neck; myofascial release

Outcome Measures

Primary Outcomes (6)

• change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention

  The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)

  at Day 0 before and immediately after intervention in both groups

• change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention

  The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)

  at Day 7 before and immediately after intervention in both groups

• SPPB (Short Physical Performance Battery test) score at day 21

  The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)

  at Day 21 in both groups before the intervention for sham group

• change of walking speed at day 0 after 1 intervention

  The subject will performed a 4m gait measurement

  at Day 0 before and immediately after intervention in both groups

• change of walking speed at day 7 after a second intervention intervention

  The subject will performed a 4m gait measurement

  at Day 7 before and immediately after intervention in both groups

• walking speed at day 21

  The subject will performed a 4m gait measurement

  at Day 21 in both groups, before the intervention for sham group

Secondary Outcomes (18)

• change in Heart Rate Variability at day 0 after 1 intervention

  at Day 0 before and immediately after intervention in both groups

• change in Heart Rate Variability at day 7 after the second intervention

  at Day 7 before and immediately after intervention in both groups

• Heart Rate Variability at day 21

  at Day 21 before the intervention for sham group

• change in cervical range of motion at day 0 after 1 intervention

  at Day 0 before and immediately after intervention in both groups

• change in cervical range of motion at day 7 after the second intervention

  at Day 7 before and immediately after intervention in both groups

Study Arms (2)

Sham (ligth touch)

SHAM COMPARATOR

Placebo intervention composed of light touch treatment on the cervical spine.

Other: Placebo intervention

Manual therapy

EXPERIMENTAL

Manual therapy applied to the cervical spine.

Other: Manual therapy

Interventions

Manual therapy OTHER

The manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7). This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine. Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses. Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7. On D21, only one assessment will be done at the beginning of the session.

Manual therapy

Placebo intervention OTHER

The Sham group receives placebo treatment twice (D0 and D7). This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy. Outcomes are evaluation before and after placebo intervention. The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group

Sham (ligth touch)

Eligibility Criteria

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

You may qualify if:

• years of age or older, of either sex
• Autonomous, able to walk ten meters alone without walking aid
• Able to understand instructions necessary for the correct performance of the measurements.

You may not qualify if:

• Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
• Patient who has an history of surgery - fracture - dislocation of the cervical spine
• Patient who has cognitive impairments (Mini Mental Statement \<20)
• Patient who has life expectancy less than 6 months.

Sponsors & Collaborators

• EZUS-LYON 1: lead

Study Sites (1)

Hôpital de la Croix-Rousse

Lyon, Rhône, 69004, France

Location

Related Publications (1)

• Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.

  PMID: 36045446 DERIVED

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Laurianne PINLOCHE, MD

  Laboratoire Interuniversitaire de Biologie de la Motricité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: July 27, 2022
• Study Start: February 4, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)