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Effect of a targeted exercise intervention in post-stroke older people.

Effect of a targeted exercise intervention on independent mobility and motor functioning in post-stroke older people

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000169741
Acronym
IN-PostStroke
Enrollment
16
Registered
2022-02-02
Start date
2024-01-31
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will test the effectiveness of target intervention or conventional physiotheraphy to recover independent mobility of older patients that have suffered a STROKE.. Patients will be randomly allocated to two groups and treated at early acute stages. Arm1 called target interention. Aims to recover balance and will attend disordered systems underlying the postural control responsible for poor functional balance. Arm2: Conventional Physiotherapy Interventions will be delivered at the Rehabilitation Unit of a large Hospitals by Physiotherapists specialised in neurological rehabilitation. Adherence will be measured as days attending treatment. The effectiveness of the interventions will be measured using several clinical scales that assess Physical function and Balance and are the Short Physical Performance Battery (SPPB and Balance Evaluation Systems Test (BESTest) and mini Balance Evaluation Systems Test (Mini-BESTest) We will assess as well validity of balance and functonal performance test (SPPB, BESTest, and Mini-BESTest) to acheive gait independent mobility . We hypothesised that patients in arm1 will experience a greater functional balance and mobility improvement and/or faster recovery of independent mobility..

Interventions

Arm1: Target intervention programme combines a repertory of standardized exercises that have been previously described in scientific literature to improve balance and are: 1) biomechanical restrictions, 2) limits of stability and verticality, 3) anticipatory responses, 4) postural responses, 5) sensory orientation, and 6) gait stability. Exercises or tasks selected will be individually adjusted to 1) patients needs, that is based on their altered or limitation identified with functional test and

Arm1: Target intervention programme combines a repertory of standardized exercises that have been previously described in scientific literature to improve balance and are: 1) biomechanical restrictions, 2) limits of stability and verticality, 3) anticipatory responses, 4) postural responses, 5) sensory orientation, and 6) gait stability. Exercises or tasks selected will be individually adjusted to 1) patients needs, that is based on their altered or limitation identified with functional test and 2) perceived difficulty of task. The last one will be used as well for exercise progression. The rehabilitation exercises are oriented as well towards the patient's choice of recovery of functional mobility. For the choice of activities, the patient is provided with the images with activities included in the ICON-FES30 and arrange them hierarchically a final question is added asking if there is any activity not contemplated that you want to add. Difficulty progression of the exercises includes (work position, activity time, amount of base of support, stability of base of support, speed of execution requested, number of displacements: direction, sense and magnitude of the displacement, present-limited-altered balance sensory systems, presence or absence of dual tasks and their modality). Patients will perform 15 different exercises or tasks per session. Each proposed exercise will have an approximate duration of 15 seconds, it will be repeated 2-3 times and the execution conditions will be altered to guarantee the alteration of the stimuli in the therapy. The intensity of the proposals will be adjusted to subjective perception of difficulty, that will have to be 3 or 4 on a scale of difficulty from 0 to 5, with 0 being no difficulty and 5 very difficult. E.g. When a patient has problems-difficulty in the sitting posture, an exercise is included, for this purpose. The indication would be: I would like you to stay seated on this chair as upright and aligned as possible. You must place the chin in line with the ear lobe, the head without inclination. The shoulders must be aligned horizontally and positioned also aligned with the hips vertically, you should perceive that the weight of the body is distributed over the chair is homogeneous over both buttocks. The trunk should be stand still, not lean forward or behind or towards either side. Please place ech arm over the arm rest of the chair. When the patient performs this exercise correctly and evaluates it between 2 or less in difficulty on a scale of 0-5, 5 being very difficult or unable to perform it, progress would be made towards an exercise of greater difficulty and vice versa. For example fold your arms across the chest. On the contrary ff the difficulty is 5=extreme, or unable to do it correctly, the difficulty will be lowered, for example, allowing support on the back of the chair. In both conditions the criteria use to adjust difficulty inolves the number of support surfaces used. Initially the partient will obtain concurrent feedback using a mirror, then without it only with indications-corrections from the physiotherapist. Intervention will commence within 1 week post-stroke. Therapeutic intervention will be conducted in Hospital and delivered by a physiotherapist specialized in neurological rehabilitation who supervise and control each therapeutic session during the intervention period. The maximum duration of therapeutic intervention for the purpose of the study will be 90 days after stroke, however could be less if the patients achieve independent mobility walking 15 meters at a speed of 1 meter per second or over. Two treatment phases will be identified, differentiated by hospital care modality 1) acute hospital post-stroke and 2) sub-acute. The transition form acute to sub-acute phase will be determined by the assigned physician to the patient, neurologist, neurosurgeon or rehabilitator at time of discharge from acute stroke ward and admission to sub-acute hospital rehabilitation unit. The transition form sub-acute phase to community living individual will be determined as well by the asigned physician to the patient, at time of discharge from sub-acute hospital rehabilitation unit. In the first phase all patients will receive 4 and a half hour (270 minutes) of weekly physiotherapy, which will be distributed in sessions of 45 minutes, 5 sessions per week from Monday to Friday. In the subacute phase, they will receive 135 minutes of weekly physical therapy in sessions, separated between them for at least 24 hours (3 sessions of 46 minutes) or (two sessions of 70 minutes). All therapy sessions will be individual (not in group). Adherence will be measured as number of days attending treatment.

Sponsors

University of the Basque Country/Universidad del Pais Vasco-Euskal Herriko Univertsitatea
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

- Community living independent living individuals before the stroke, who are acutely hospitalized due to being diagnosed after having suffered their first stroke at the Royo Villanova (HRV) or the Provincial Nuestra Señora de Gracia de Zaragoza (HNSG) and the Cruces Hospital in Bizkaia ( HC) - Cognitive status preserved and - Able to follow the instructions, both during testing and intervention. - Ability to maintain a sitting position on a chair without assisstance with a back

Exclusion criteria

- Severe heart disease or severe bronchopathies - Other types of medical conditions that prevent the treatment from being implemented - Cognitive impairment - Inability to understand the instructions during the test or intervention. - Unstable orthopedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems, - Inability to maintain a sitting position on a chair without assisstance with a back

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026