Replacing canes with an elasticated orthotic-garment in chronic stroke patients - The influence on gait and balance. A series of N-of-1 trials.
Study Goal
To investigate whether replacing canes with an elasticated orthotic-garment improves balance and gait-function in chronic stroke survivors.
Results Summary
The study found significant improvements in Functional-Gait-Assessment (FGA) scores and reduced trunk-sway in some participants when using the orthotic-garment, indicating better stability. However, results varied by participant during follow-up, with some maintaining improvements, others stabilizing, and one deteriorating.
Population
Four chronic stroke survivors who previously used canes.
Effective Dosage
Orthotic-garment worn throughout the day with maximal cane-use reduction.
Duration
Phase A (9-12 weeks), Phase B (9-16 weeks), Phase C (9-10 weeks).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
replacing canes with an elasticated orthotic-garment | increase | Functional-Gait-Assessment (FGA) | cane using chronic stroke survivors | - | significant improvements | #1 |
replacing canes with an elasticated orthotic-garment | decrease | Trunk-sway during walking measured as Total-Angle-Area (TAA) | cane using chronic stroke survivors | - | reduced | #2 |
replacing canes with an elasticated orthotic-garment | increase | Trunk-sway during walking | cane using chronic stroke survivors | - | increased stability | #3 |
orthotic-garment worn throughout the day with maximal cane-use reduction | increase | Functional-Gait-Assessment (FGA) | P2 | - | improvement continued | #4 |
orthotic-garment worn throughout the day with maximal cane-use reduction | no change | Functional-Gait-Assessment (FGA) | P1 and P4 | - | stabilized | #5 |
orthotic-garment worn throughout the day with maximal cane-use reduction | decrease | Functional-Gait-Assessment (FGA) | P3 | - | deteriorated | #6 |
orthotic-garment worn throughout the day with maximal cane-use reduction | increase | Minimal-Clinical-Important-Difference | P2 & P4 | 6 points-change | achieved | #7 |
orthotic-garment worn throughout the day with maximal cane-use reduction | decrease | Trunk-sway during walking | two participants | - | reduced | #8 |
orthotic-garment worn throughout the day with maximal cane-use reduction | decrease | Trunk-sway during walking | three participants | - | reduced | #9 |
orthotic-garment worn throughout the day with maximal cane-use reduction | no change | Total-Angle-Area (TAA) | cane using chronic stroke survivors | - | no changes were statistically significant | #10 |
participant-determined follow-up: either no walking-aid, orthotic-garment or cane | decrease | cane-usage | P1 | 25% | reduced | #11 |
participant-determined follow-up: either no walking-aid, orthotic-garment or cane | decrease | walking-aid usage | P2 | - | independent-walking with no assistive-device | #12 |
participant-determined follow-up: either no walking-aid, orthotic-garment or cane | no change | walking-aid usage | S3 | - | usual cane-usage | #13 |
participant-determined follow-up: either no walking-aid, orthotic-garment or cane | decrease | walking-aid usage | P4 | 2-3 days-a-week | orthotic-garment with reduced cane-usage | #14 |
participant-determined follow-up: either no walking-aid, orthotic-garment or cane | no change | walking-aid usage | P4 | 4-5 days | usual cane-usage | #15 |
OBJECTIVE: To investigate the effect of replacing canes with an elasticated orthotic-garment on balance and gait-function in chronic stroke survivors. DESIGN: Experimental, N-of-1 series with a replicated, ABC design with randomised phase duration in a home setting. PARTICIPANTS: Four cane using chronic stroke survivors (P1-4). INTERVENTIONS: Phase A (9-12 weeks) cane-walking "as usual" to establish baseline values; Phase B (9-16 weeks) intervention: orthotic-garment worn throughout the day with maximal cane-use reduction; Phase C (9-10 weeks) participant-determined follow-up: either no walking-aid, orthotic-garment or cane. OUTCOME MEASURES: Primary: Functional-Gait-Assessment (FGA), Secondary: Trunk-sway during walking measured as Total-Angle-Area (TAA° RESULTS: Visual and statistical analysis of results showed significant improvements in FGA from phase A to B in all participants. Improvement continued in phase C in P2, stabilized in P1 and P4 and deteriorated in P3. A Minimal-Clinical-Important-Difference of 6 points-change was achieved in P2 & P4. Trunk-sway reduced during walking, indicating increased stability, in two participants from phase A to B and in three participants from A to C but no TAA changes were statistically significant. In phase C participant-selected walking-aids were: P1 cane-usage reduced by 25%, P2 independent-walking with no assistive-device, S3 usual cane-usage, P4 orthotic-garment with reduced cane-usage 2-3 days-a-week, usual cane-usage 4-5 days. CONCLUSIONS: Although walking ability is multifactorial these results indicate that the choice of walking-aids can have a specific and clinically relevant impact on gait following stroke. "Hands-free" assistive-devices may be more effective than canes in improving gait-function in some patients. CLINICALTRIALS. GOV ID: NCT03642444.