Exercise Therapy Program on Acquired Brain Injury

NCT05358470 | Completed DMC

• 1 other identifier: Exercise-acquired brain injury
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the physical and psychosocial effects of a exercise therapy and adapted physical activity program based on racket sports for ambulant people with acquired brain injury will be investigated.

Conditions

Acquired Brain Injury

Keywords

Exercise therapy; Physical Therapy; Exercise; Sports for persons with disabilities

Outcome Measures

Primary Outcomes (6)

• Functional capacity: 10 Meter Walk Test

  \- 10 Meter Walk Test: The 10MWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

  Baseline, Change from Baseline at 8th week

• Motor control of the upper limb test: Fugl-Meyer Upper Extremity (FM-UE)

  FM-UE is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.

  Baseline, Change from Baseline at 8th week

• Mobility Test: Timed Up and Go (TUG)

  This test is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. This test is rated on a scale of second measurement, considering less than 10 second as "normal function" and more than 30 seconds as "severely abnormal function".

  Baseline, Change from Baseline at 8th week

• Balance Test: Balance Berg Scale (BBS)

  This scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It does not include the assessment of gait. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

  Baseline, Change from Baseline at 8th week

• Health-related quality of life Questionnaire: Short Form 36 (SF36) v2

  This questionnaire evaluate general health status in eight domains: physical function, role physical, bodily pain, general health, vitality, social function, role emotional and mental health; which are also reduced to Physical and Mental Component Summary scores. Values above or below 50 (the normative score from the general population) are interpreted as better or worse than the reference population, respectively.

  Baseline, Change from Baseline at 8th week

• Functional capacity: 6 Minute Walk Test

  \- 6 Minutes Walk Test: The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The measurement is considered by meters, so the more meters the user is able to get, the more distance and "normal functioning" will register.

  Baseline, Change from Baseline at 8th week

Secondary Outcomes (4)

• Level of physical activity questionnaire

  Baseline, Change from Baseline at 8th week

• Sociodemographics questionnaire

  Baseline

• Anthropometric data - Weight

  Baseline

• Anthropometric data - Height

  Baseline

Study Arms (2)

Exercise therapy and adapted physical activity-based intervention

EXPERIMENTAL

The intervention in the experimental group (EG) consists of a exercise therapy and adapted physical activity program based on racket sports. The immediate EG will receive sixteen, twice a week, one-hour sessions of group-based, racket sports specific fundamental movement skills training. All sessions will be guided and supervised by a physiotherapist and delivered in groups of 5 participants to promote exchange and conviviality and to optimize the rates of participation and compliance.

Other: Exercise therapy and adapted physical activity-based program

Usual care

NO INTERVENTION

Participants in the CG receive conventional management with general physical activity recommendation.

Interventions

Exercise therapy and adapted physical activity-based program OTHER

Exercise therapy and adapted physical activity program based on racket sports

Exercise therapy and adapted physical activity-based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with a medical diagnosis of acquired brain injury in subacute or chronic stages.
• To be aged \>18 years at study entry
• To have an independent gait without the need of technical aids: a score of 3, 4 or 5 from the Functional Ambulation Categories (FAC) walking test.
• Be able to understand simple instructions from the program protocols as well as perform baseline and post-intervention assessments.

You may not qualify if:

• Not have a completed and signed informed consent form.
• Non-attendance and/or non-collaboration to 70% of the program sessions.
• To have medical co-morbidities that contraindicate physical exercise safely (e.g. cardiac or respiratory instability, uncontrolled seizures)
• Non-collaboration during the pre- and post-tests of the program.

Sponsors & Collaborators

• Universidade da Coruña: lead

Study Sites (1)

Second Part Foundation

Madrid, Spain

Location

MeSH Terms

Conditions

Brain Injuries; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Department of Physiotherapy, Medicine and Biomedical Sciences. Universidade da Coruña

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 3, 2022
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 1, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

ES (1)